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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
Cardiovascular Monitoring Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
EZT
Pacemaker, Bladder
3
Product Code
EZW
Stimulator, Electrical, Implantable, For Incontinence
3
Product Code
EZY
Device, Incontinence, Mechanical/Hydraulic
3
Product Code
FAH
Dilator, Urethral, Mechanical
2
Product Code
BSS
Tube, Nasogastric
2
Product Code
EXA
Selector, Size, Ostomy
1
Product Code
EXB
Collector, Ostomy
1
Product Code
EXD
Irrigator, Ostomy
2
Product Code
EXE
Protector, Ostomy
1
Product Code
EXF
Bag, Bile Collecting
2
Product Code
EXG
Bag, Urine Collecting, Ureterostomy
1
Product Code
EXH
Bag, Urinary, Ileostomy
1
Product Code
EXI
Device, Paste-On For Incontinence, Sterile
1
Product Code
EXJ
Device, Incontinence, Urosheath Type, Sterile
1
Product Code
EXN
Support, Hernia
1
Product Code
EYA
Stylet, Ureteral
1
Product Code
EYB
Catheter, Ureteral, Gastro-Urology
2
Product Code
EYC
Catheter, Upper Urinary Tract
2
Product Code
EYI
Adaptor, Ureteral Catheter
1
Product Code
EYJ
Holder, Ureteral Catheter
1
Product Code
EYK
Connector, Ureteral Catheter
1
Product Code
EYQ
Garment, Protective, For Incontinence
1
Product Code
EYT
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
1
Product Code
EYZ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
1
Product Code
EZB
Stylet For Catheter, Gastro-Urology
1
Product Code
EZC
Catheter, Coude
2
Product Code
EZD
Catheter, Straight
2
Product Code
EZK
Catheter, Retention Type
2
Product Code
EZL
Catheter, Retention Type, Balloon
2
Product Code
EZM
Dilator, Esophageal (Metal Olive) Gastro-Urology
2
Product Code
EZN
Dilator, Catheter, Ureteral
2
Product Code
EZQ
Pouch, Colostomy
1
Product Code
EZR
Cement, Stomal Appliance, Ostomy
1
Product Code
EZS
Appliance, Colostomy, Disposable
1
Product Code
FAQ
Bag, Urine Collection, Leg, For External Use, Sterile
1
Product Code
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
2
Product Code
FAX
Bougie, Urological
1
Product Code
FBM
Cannula And Trocar, Suprapubic, Non-Disposable
1
Product Code
FBR
Urethrometer
1
Product Code
FBW
Filiform And Filiform Follower
1
Product Code
FBX
Sound, Urethral, Metal Or Plastic
1
Product Code
FCB
Bag, Hemostatic
2
Product Code
FCE
Enema Kit
1
Product Code
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
2
Product Code
FCN
Urinary Drainage Collection Kit, For Indwelling Catheter
2
Product Code
FEF
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
2
Product Code
FEG
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
2
Product Code
FEW
Catheter, Malecot
2
Product Code
FEX
Instrument, Catheter, Punch
1
Product Code
FEZ
Catheter And Tube, Suprapubic
2
Product Code
FFA
Tube, Drainage, Suprapubic
2
Product Code
FFH
Collector, Urine, Pediatric, For Indwelling Catheter
2
Product Code
FFP
Dilator, Rectal
1
Product Code
FFW
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
2
Product Code
FGD
Catheter, Retention, Barium Enema With Bag
2
Product Code
FGE
Stents, Drains And Dilators For The Biliary Ducts
2
Product Code
FGF
Catheter, Ureteral Disposable (X-Ray)
2
Product Code
FGH
Catheter, Double Lumen Female Urethrographic
2
Product Code
FGI
Catheter, Urethrographic, Male
2
Product Code
FHA
Clamp, Penile
1
Product Code
FHS
Dialyzer, Single Coil
2
Product Code
FHT
Set, Gavage, Infant, Sterile
2
Product Code
FIA
Chair, Dialysis, Unpowered, Without Scales
1
Product Code
FIB
Protector, Transducer, Dialysis
2
Product Code
FID
Tubing, Dialysate
2
Product Code
FIE
Needle, Fistula
2
Product Code
FIF
Set, Dialysis, Single Needle With Uni-Directional Pump
2
Product Code
FIG
Clamp, Tubing, Blood, Automatic
2
Product Code
FIH
Pump, Infusion Or Syringe, Extra-Luminal
2
Product Code
FII
System, Dialysate Delivery, Sealed
2
Product Code
FIJ
System, Dialysate Delivery, Recirculating, Single Pass
2
Product Code
FIK
System, Dialysate Delivery, Recirculating
2
Product Code
FIL
System, Dialysate Delivery, Single Pass
2
Product Code
FIN
Tank, Holding, Dialysis
2
Product Code
FIP
Subsystem, Water Purification
2
Product Code
K
21
1035
U9000 Plus Ultrafilter
2
Cleared 510(K)
K
20
0670
EON Portable RO Water Purification System
2
Cleared 510(K)
K
19
2398
Millenium HX
2
Cleared 510(K)
K
18
2367
DIASAFEplusUS
2
Cleared 510(K)
K
17
1099
EON Portable Reverse Osmosis Water Purification System
2
Cleared 510(K)
K
16
1304
EndoPur Filter
2
Cleared 510(K)
K
16
1844
Matrix Pre-Treatment Controller
2
Cleared 510(K)
K
15
3329
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
2
Cleared 510(K)
K
14
3617
AquaC UNO H
2
Cleared 510(K)
K
15
1637
UPT Series Medical RO Water System
2
Cleared 510(K)
K
14
2285
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
2
Cleared 510(K)
K
13
3149
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
13
3829
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
2
Cleared 510(K)
K
13
3783
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
2
Cleared 510(K)
K
13
1904
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
2
Cleared 510(K)
K
13
1622
MROZ REVERSE OSMOSIS SYSTEM
2
Cleared 510(K)
K
12
3282
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
2
Cleared 510(K)
K
12
4059
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
2
Cleared 510(K)
K
12
1022
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
2
Cleared 510(K)
K
11
2331
BIOPURE PORTABLE RO SYSTEMS
2
Cleared 510(K)
K
11
1740
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
2
Cleared 510(K)
K
11
0285
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
2
Cleared 510(K)
K
11
0578
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
10
2892
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
2
Cleared 510(K)
K
09
3608
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
2
Cleared 510(K)
K
09
2481
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
2
Cleared 510(K)
K
08
3712
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
2
Cleared 510(K)
K
09
0885
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
2
Cleared 510(K)
K
08
2400
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
2
Cleared 510(K)
K
08
0703
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
2
Cleared 510(K)
K
07
2158
AQUA PURE DEIONIZER EXCHANGE SERVICE
2
Cleared 510(K)
K
07
1104
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
2
Cleared 510(K)
K
06
1782
GAMBRO POSICLEAR
2
Cleared 510(K)
K
06
0942
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
2
Cleared 510(K)
K
05
1620
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
2
Cleared 510(K)
K
04
2018
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
2
Cleared 510(K)
K
04
3344
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
2
Cleared 510(K)
K
04
2797
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
04
1884
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
04
2089
NX STAGE WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
03
1832
MEGA PURE CART
2
Cleared 510(K)
K
04
1163
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
2
Cleared 510(K)
K
03
3648
PERFORMANCE WATER TREATMENT SYSTEM
2
Cleared 510(K)
K
03
0348
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
2
Cleared 510(K)
K
03
2004
AQUABOSS ECORO DIA 50
2
Cleared 510(K)
K
03
0652
MEDRO SPD
2
Cleared 510(K)
K
02
1560
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
02
2448
WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
03
0059
PORTABLE RO+ MODEL MROS09
2
Cleared 510(K)
K
02
2747
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
2
Cleared 510(K)
K
01
1005
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
00
1755
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
02
1352
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
2
Cleared 510(K)
K
01
3677
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
2
Cleared 510(K)
K
01
4169
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
2
Cleared 510(K)
K
00
3957
DIACLEAR ULTRAFILTER
2
Cleared 510(K)
K
01
0592
AQUA WATER TREATMENT FOR HEMODIALYSIS
2
Cleared 510(K)
K
00
3877
MAR COR SERVICES SEMPER PURE RO MACHINE
2
Cleared 510(K)
K
00
2045
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
99
4292
WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
99
4279
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
2
Cleared 510(K)
K
00
1282
AIW WATER SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
00
0249
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
2
Cleared 510(K)
K
00
1811
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
2
Cleared 510(K)
K
99
1495
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
2
Cleared 510(K)
K
99
3806
DIALGUARD ENDOTOXIN REMOVAL DEVICE
2
Cleared 510(K)
K
99
3877
NELSON WATER SYSTEMS FOR HEMODIALYSIS
2
Cleared 510(K)
K
99
3520
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
99
1519
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
99
3200
MD 420/440/460/470/480/490
2
Cleared 510(K)
K
99
2786
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
2
Cleared 510(K)
K
99
1916
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
98
3239
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
2
Cleared 510(K)
K
98
3512
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
98
3126
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
2
Cleared 510(K)
K
98
1680
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
98
0182
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
97
4899
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
2
Cleared 510(K)
K
98
1085
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
2
Cleared 510(K)
K
97
4127
HYDRA METER
2
Cleared 510(K)
K
96
4539
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
2
Cleared 510(K)
K
94
5559
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
2
Cleared 510(K)
K
94
4493
REVERSE OSMOSIS SYSTEM
2
Cleared 510(K)
K
95
4928
PORTABLE REVERSE OSMOSIS MACHINE
2
Cleared 510(K)
K
95
4349
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
2
Cleared 510(K)
K
94
5066
AWESMOSIS
2
Cleared 510(K)
K
94
4767
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
2
Cleared 510(K)
K
92
4695
ASEPTECH PORTABLE RO+ SYSTEM
2
Cleared 510(K)
K
95
2215
SERIM HISENSE TEST KIT
2
Cleared 510(K)
K
92
0186
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
2
Cleared 510(K)
K
94
4385
MD400 A/B/C/D/E/F/G
2
Cleared 510(K)
K
94
5136
RENAGUARD DIALYSATE FILTER
2
Cleared 510(K)
K
93
1595
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
2
Cleared 510(K)
K
93
4848
MASTER ALERT
2
Cleared 510(K)
K
91
5258
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
2
Cleared 510(K)
K
89
4300
SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
2
Cleared 510(K)
K
89
4106
DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
2
Cleared 510(K)
K
87
1242
REVERSE OSMOSIS WATER PURIFICATION SYSTEM
2
Cleared 510(K)
K
87
3487
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES
2
Cleared 510(K)
K
86
3720
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
2
Cleared 510(K)
K
84
2215
ASCORBIC ACID
2
Cleared 510(K)
K
84
1403
HEMO-RO WATER PURIFICATION SYS
2
Cleared 510(K)
K
82
2385
EXTRAPURE REVERSE OSMOSIS WATER UNIT
2
Cleared 510(K)
K
81
1678
GAMBRO WATER PURIFICATION MONITOR WRD
2
Cleared 510(K)
K
80
2474
CMR 300, ROWATER TREATMENT UNIT
2
Cleared 510(K)
K
80
0305
WATER CONDUCTIVITY MONITOR & CONTROLLER
2
Cleared 510(K)
K
79
1086
CENTRY 2 SYSTEM #016, 103, 016, 104
2
Cleared 510(K)
K
77
1763
HEMO-RO
2
Cleared 510(K)
FIQ
Cannula, A-V Shunt
2
Product Code
FIR
Pump, Blood, Extra-Luminal
2
Product Code
FIS
Flowmeter, Dialysate
2
Product Code
FIW
Alarm, Pillow Pressure
2
Product Code
FIZ
Meter, Conductivity, Non-Remote
2
Product Code
FJA
Manometer, Water
2
Product Code
FJB
Detector, Dialysate Level
2
Product Code
FJC
Detector, Blood Level
2
Product Code
FJD
Detector, Leak, Blood
2
Product Code
FJF
Detector, Air Bubble
2
Product Code
FJG
Dialyzer, Parallel Flow
2
Product Code
FJH
Dialyzer, Disposable
2
Product Code
FJI
Dialyzer, Capillary, Hollow Fiber
2
Product Code
FJJ
Dialyzer, Twin Coil
2
Product Code
FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
2
Product Code
FJM
Guard, Shunt
2
Product Code
FJN
Stabilizer, Shunt
2
Product Code
FJO
Plier, Tube
1
Product Code
FJP
Adaptor, Y
2
Product Code
FJQ
Connector, Shunt
1
Product Code
FJR
Forceps, Disconnect
1
Product Code
FJS
Catheter, Peritoneal, Long-Term Indwelling
2
Product Code
FJT
Intracatheter, Dialysis
2
Product Code
FJW
Ring, Joint
1
Product Code
FJX
Ring, Crimp
1
Product Code
FJY
Plier, Crimp
1
Product Code
FJZ
Declotting Tray, Kit (Including Contents)
2
Product Code
FKA
Dilator, Vessel
2
Product Code
FKB
Connector, Blood Tubing, Infusion T
2
Product Code
FKC
Clamp, Cannula
1
Product Code
FKD
Canister, Coil
2
Product Code
FKE
Tie, Dialysis
1
Product Code
FKF
Gun, Tie, Dialysis
1
Product Code
FKG
Tray, Start/Stop (Including Contents), Dialysis
1
Product Code
FKH
Solution-Test Standard-Conductivity, Dialysis
2
Product Code
FKI
Set, Dialyzer Holder
2
Product Code
FKJ
Filter, Blood, Dialysis
2
Product Code
FKL
Insert, Pump, Blood
2
Product Code
FKM
Adaptor, Fistula
2
Product Code
FKN
Adaptor, Shunt
2
Product Code
FKO
Catheter, Peritoneal Dialysis, Single Use
2
Product Code
FKP
System, Dialysate Delivery, Single Patient
2
Product Code
FKQ
System, Dialysate Delivery, Central Multiple Patient
2
Product Code
FKR
Subsystem, Proportioning
2
Product Code
FKT
System, Dialysate Delivery, Sorbent Regenerated
2
Product Code
FKW
Tip, Vessel
2
Product Code
FKX
System, Peritoneal, Automatic Delivery
2
Product Code
FKY
Connector, Tubing, Dialysate
2
Product Code
FLA
Monitor, Temperature, Dialysis
2
Product Code
FLB
Meter, Conductivity, Induction, Remote Type
2
Product Code
FLC
Station, Dialysis Control, Negative Pressure Type
2
Product Code
FLD
Apparatus, Hemoperfusion, Sorbent
2
Product Code
FOC
Bag, Urine Collection, Newborn
2
Product Code
FON
Bag, Drainage, With Adhesive, Ostomy
1
Product Code
FPD
Tube, Feeding
2
Product Code
FRQ
Tube, Levine
2
Product Code
GBL
Catheter, Ureteral, General & Plastic Surgery
2
Product Code
GBM
Catheter, Urethral
2
Product Code
GBT
Catheter, Rectal
2
Product Code
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
2
Product Code
GDS
Bag, Stomal
1
Product Code
KDH
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
2
Product Code
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
2
Product Code
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
2
Product Code
KDK
Container, Transport, Kidney
2
Product Code
KDL
Set, Perfusion, Kidney, Disposable
2
Product Code
KDN
System, Perfusion, Kidney
2
Product Code
KGC
Tube, Gastro-Enterostomy
2
Product Code
KNQ
Dilator, Esophageal
2
Product Code
KNR
Adapter, A-V Shunt Or Fistula
2
Product Code
KNT
Tubes, Gastrointestinal (And Accessories)
2
Product Code
KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
2
Product Code
KNY
Accessories, Catheter, G-U
2
Product Code
KNZ
Accessories, A-V Shunt
2
Product Code
KOB
Catheter, Suprapubic (And Accessories)
2
Product Code
KOC
Accessories, Blood Circuit, Hemodialysis
2
Product Code
KOD
Catheter, Urological
2
Product Code
KOE
Dilator, Urethral
2
Product Code
KPF
System, Dialysate Delivery, Semi-Automatic, Peritoneal
2
Product Code
KPH
Catheter, Rectal For Continent Ileostomy
1
Product Code
KPI
Stimulator, Electrical, Non-Implantable, For Incontinence
2
Product Code
KPL
Colonic Irrigation System
2
Product Code
KPM
Shunt, Peritoneal
2
Product Code
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
2
Product Code
KPP
Peritoneal Dialysate Filter
2
Product Code
KQQ
Tubing, Dialysate (And Connector)
2
Product Code
KQR
Detector, Air Or Foam
2
Product Code
KXM
System Accessories, Extracorporeal
2
Product Code
LBW
Set, Dialysis, Single Needle (Co-Axial Flow)
2
Product Code
LCG
Intestinal Splinting Tubes
2
Product Code
LFJ
Catheter, Subclavian
2
Product Code
LFK
Catheter, Femoral
2
Product Code
LIF
Dialyzer Reprocessing System
2
Product Code
LJH
System, Irrigation, Urological
2
Product Code
LKY
Device, External Penile Rigidity
2
Product Code
LLB
System, Blood, Extracorporeal And Accessories
2
Product Code
LNS
Lithotriptor, Extracorporeal Shock-Wave, Urological
2
Product Code
LQR
Dislodger, Stone, Biliary
2
Product Code
LRI
Ph Meter For Dialysis Hydrogen Ion Concentration
2
Product Code
MJC
Catheter, Urological (Antimicrobial) And Accessories
2
Product Code
MLW
Warmer, Peritoneal Dialysate
2
Product Code
MNG
External Urethral Occluder, Urinary Incontinence-Control, Female
1
Product Code
MNV
Strip, Dialysate Ph Indicator
2
Product Code
MON
System, Hemodialysis, Remote Accessories
1
Product Code
MPB
Catheter, Hemodialysis, Non-Implanted
2
Product Code
MQS
System, Hemodialysis, Access Recirculation Monitoring
2
Product Code
MSB
System And Accessories, Isolated Heart, Transport And Preservation
2
Product Code
MSD
Catheter, Hemodialysis, Implanted
2
Product Code
MSE
Hemodialyzer, Re-Use, Low Flux
2
Product Code
MSF
Hemodialyzer, Re-Use, High Flux
2
Product Code
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
2
Product Code
MSZ
Strip, Test, Reagent, Residuals For Dialysate
2
Product Code
NAM
Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction
2
Product Code
NDS
Media, Culture, Ex Vivo, Tissue And Cell
2
Product Code
NFK
Kit, Repair, Catheter, Hemodialysis
2
Product Code
NHV
System, Water Purification, General Medical Use
2
Product Code
NIE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
2
Product Code
NIF
Catheter, Hemodialysis, Triple Lumen, Implanted
2
Product Code
NML
Catheter, Biliary, Reprocessed
2
Product Code
NNE
Needle, Fistula, Reprocessed
2
Product Code
NNG
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
2
Product Code
NNW
Bag, Urine Collection, Leg, For External Use, Non-Sterile
1
Product Code
NNX
Device, Incontinence, Urosheath Type, Non-Sterile
1
Product Code
NNY
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
1
Product Code
NNZ
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
1
Product Code
NOA
Device, Paste-On For Incontinence, Non-Sterile
1
Product Code
NOO
Clamp, Dialysis Arm
1
Product Code
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
2
Product Code
NQJ
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
2
Product Code
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
2
Product Code
NUB
Colonic Irrigation System, General Well Being
3
Product Code
NYU
Catheter, Hemodialysis, Implanted, Coated
2
Product Code
NWO
Kit, Catheter, Urinary (Exludes Hiv Testing)
2
Product Code
NWP
Suprapubic Cystostomy Catheter Kit
2
Product Code
NWQ
Kit, Catheter, External, Male (Excludes Hiv Testing)
2
Product Code
NWR
Kit, Catheter, Foley (Excludes Hiv Testing)
2
Product Code
NZU
Collector, Urine, Powered, Non Indwelling Catheter
1
Product Code
ODN
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
2
Product Code
ODX
Autonomous Extracorporeal Blood Leak Detector/Alarm
2
Product Code
OHR
Catheter Care Tray
2
Product Code
ONW
Hemodialysis System For Home Use
2
Product Code
ONY
Oral Removable Retainer For Weight Management
2
Product Code
PBP
Rectal Insert
2
Product Code
PCU
Pancreatic Stent, Covered, Metallic, Removable
2
Product Code
PEH
Hemodialysis Catheter Luer End Cap
2
Product Code
PEV
Dialysis Administration Kit
2
Product Code
PEW
Implantable Transprostatic Tissue Retractor System
2
Product Code
PFH
Venous Window Needle Guide
2
Product Code
PIA
Vibrator For Climax Control Of Premature Ejaculation
2
Product Code
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
2
Product Code
PIE
Esophageal Dilator With Balloon And Electrode Sensors
2
Product Code
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
2
Product Code
QGC
Suprapubic Catheter Accessories
1
Product Code
PIH
Urethral Insert With Pump For Bladder Drainage
2
Product Code
PIN
Kidney Perfusion Kit
2
Product Code
PIO
Enteral Specific Transition Connectors
2
Product Code
PJH
Dynamic Rectal Control System
2
Product Code
PKI
Fully Subcutaneous Implanted Hemodialysis Catheter
2
Product Code
PLI
Gastrointestional Tube Holder
2
Product Code
PLQ
Enzyme Packed Cartridge
2
Product Code
PNB
Biliary Stent System For Benign Strictures
2
Product Code
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
2
Product Code
PNR
Enteral Syringes With Enteral Specific Connectors
2
Product Code
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
2
Product Code
PPA
Bladder Irrigation Kit
2
Product Code
PPB
Foley Catheter Kit (Excludes Hiv Testing)
2
Product Code
PPC
Male External Catheterization Kit (Excludes Hiv Testing)
2
Product Code
PPD
Universal Drainage Tray
2
Product Code
PPF
Urinary Irrigation Kit
2
Product Code
PPG
Urinary Drainage Collection Kit
2
Product Code
PPH
Single Needle With Uni-Directional Pump Kit
2
Product Code
PPI
Hemodialysis Tray (Not A Start/Stop Kit)
2
Product Code
PPJ
Peritoneal Dialysis Administration Kit
2
Product Code
PPK
Peritoneal Dialysis Tubing Kit
2
Product Code
PPL
Single Needle (Co-Axial Flow) Dialysis Kit
2
Product Code
PPO
Multi-Lumen Hemodialysis Catheterization Kit
2
Product Code
PQE
Ostomy Care Kit
1
Product Code
PRM
Enteral Administration Kit (Adult & Pediatric)
2
Product Code
PRO
Anti-Regurgitation Blood Tubing Kit
2
Product Code
PRP
Balloon Gastrostomy Tube Kit
2
Product Code
PRQ
Esophageal Dilator Kit
2
Product Code
PRR
Feeding Tube Kit
2
Product Code
PRS
Gastric Colonic Catheter Irrigation Kit
2
Product Code
PRT
Gastric Irrigation And Aspiration Kit
2
Product Code
PRW
Gastrointestinal Tube Kit
2
Product Code
PRX
Gastrostomy Guide Wire Placement Kit
2
Product Code
PRY
Gastrostomy Jejunostomy Feeding Tube Kit
2
Product Code
PRZ
Gastrostomy Tube Kit
2
Product Code
PSA
Laparoscopic Jejunostomy Kit
2
Product Code
PSB
Nasogastric Feed Tube Kit
2
Product Code
PSC
Nasogastric-Gastrojejunal Kit
2
Product Code
PSD
Laparoscopic Gastrostomy Kit
2
Product Code
PSE
Needle Catheter Jejunostomy Kit
2
Product Code
PSF
Non-Balloon Replacement Gastrostomy System
2
Product Code
PSG
Percutaneous Endoscopic Gastrostomy Kit
2
Product Code
PSH
Percutaneous Replacement Gastrostomy Tube Kit
2
Product Code
PSJ
Rectal Dilator Kit
1
Product Code
PSK
Replacement Gastrostomy Feeding Catheter Tray
2
Product Code
PSX
Chlorine Meter
2
Product Code
PTK
Pediatric Esophageal Atresia Anastomosis Device
3
Product Code
PTT
Biliary Catheter For Irrigation And Contrast Injection, Exempt
2
Product Code
PTU
Catheter, Peritoneal, Long-Term Indwelling, Exempt
2
Product Code
PTV
Catheter, Peritoneal Dialysis, Single Use, Exempt
2
Product Code
PTW
System, Peritoneal, Automatic Delivery, Exempt
2
Product Code
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
2
Product Code
QGD
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
1
Product Code
QGE
Biliary Stent, Drain, And Dilator Accessories
1
Product Code
QON
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
3
Product Code
QRC
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
2
Product Code
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K121022
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AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121022
510(k) Type
Traditional
Applicant
AMERIWATER
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/17/2012
Days to Decision
166 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Cardiovascular Monitoring Devices
Diagnostic Devices
General Hospital and Personal Use Miscellaneous Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Obstetrical and Gynecological Diagnostic Devices
Obstetrical and Gynecological Surgical Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
EZT
Pacemaker, Bladder
EZW
Stimulator, Electrical, Implantable, For Incontinence
EZY
Device, Incontinence, Mechanical/Hydraulic
FAH
Dilator, Urethral, Mechanical
BSS
Tube, Nasogastric
EXA
Selector, Size, Ostomy
EXB
Collector, Ostomy
EXD
Irrigator, Ostomy
EXE
Protector, Ostomy
EXF
Bag, Bile Collecting
EXG
Bag, Urine Collecting, Ureterostomy
EXH
Bag, Urinary, Ileostomy
EXI
Device, Paste-On For Incontinence, Sterile
EXJ
Device, Incontinence, Urosheath Type, Sterile
EXN
Support, Hernia
EYA
Stylet, Ureteral
EYB
Catheter, Ureteral, Gastro-Urology
EYC
Catheter, Upper Urinary Tract
EYI
Adaptor, Ureteral Catheter
EYJ
Holder, Ureteral Catheter
EYK
Connector, Ureteral Catheter
EYQ
Garment, Protective, For Incontinence
EYT
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
EYZ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
EZB
Stylet For Catheter, Gastro-Urology
EZC
Catheter, Coude
EZD
Catheter, Straight
EZK
Catheter, Retention Type
EZL
Catheter, Retention Type, Balloon
EZM
Dilator, Esophageal (Metal Olive) Gastro-Urology
EZN
Dilator, Catheter, Ureteral
EZQ
Pouch, Colostomy
EZR
Cement, Stomal Appliance, Ostomy
EZS
Appliance, Colostomy, Disposable
FAQ
Bag, Urine Collection, Leg, For External Use, Sterile
FAT
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
FAX
Bougie, Urological
FBM
Cannula And Trocar, Suprapubic, Non-Disposable
FBR
Urethrometer
FBW
Filiform And Filiform Follower
FBX
Sound, Urethral, Metal Or Plastic
FCB
Bag, Hemostatic
FCE
Enema Kit
FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FCN
Urinary Drainage Collection Kit, For Indwelling Catheter
FEF
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
FEG
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
FEW
Catheter, Malecot
FEX
Instrument, Catheter, Punch
FEZ
Catheter And Tube, Suprapubic
FFA
Tube, Drainage, Suprapubic
FFH
Collector, Urine, Pediatric, For Indwelling Catheter
FFP
Dilator, Rectal
FFW
String And Tubes, Gastrointestinal, To Locate Internal Bleeding
FGD
Catheter, Retention, Barium Enema With Bag
FGE
Stents, Drains And Dilators For The Biliary Ducts
FGF
Catheter, Ureteral Disposable (X-Ray)
FGH
Catheter, Double Lumen Female Urethrographic
FGI
Catheter, Urethrographic, Male
FHA
Clamp, Penile
FHS
Dialyzer, Single Coil
FHT
Set, Gavage, Infant, Sterile
FIA
Chair, Dialysis, Unpowered, Without Scales
FIB
Protector, Transducer, Dialysis
FID
Tubing, Dialysate
FIE
Needle, Fistula
FIF
Set, Dialysis, Single Needle With Uni-Directional Pump
FIG
Clamp, Tubing, Blood, Automatic
FIH
Pump, Infusion Or Syringe, Extra-Luminal
FII
System, Dialysate Delivery, Sealed
FIJ
System, Dialysate Delivery, Recirculating, Single Pass
FIK
System, Dialysate Delivery, Recirculating
FIL
System, Dialysate Delivery, Single Pass
FIN
Tank, Holding, Dialysis
FIP
Subsystem, Water Purification
K
21
1035
U9000 Plus Ultrafilter
K
20
0670
EON Portable RO Water Purification System
K
19
2398
Millenium HX
K
18
2367
DIASAFEplusUS
K
17
1099
EON Portable Reverse Osmosis Water Purification System
K
16
1304
EndoPur Filter
K
16
1844
Matrix Pre-Treatment Controller
K
15
3329
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
K
14
3617
AquaC UNO H
K
15
1637
UPT Series Medical RO Water System
K
14
2285
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
K
13
3149
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K
13
3829
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
K
13
3783
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
K
13
1904
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
K
13
1622
MROZ REVERSE OSMOSIS SYSTEM
K
12
3282
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
K
12
4059
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
K
12
1022
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
K
11
2331
BIOPURE PORTABLE RO SYSTEMS
K
11
1740
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K
11
0285
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K
11
0578
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K
10
2892
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K
09
3608
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K
09
2481
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
K
08
3712
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K
09
0885
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K
08
2400
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K
08
0703
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
K
07
2158
AQUA PURE DEIONIZER EXCHANGE SERVICE
K
07
1104
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K
06
1782
GAMBRO POSICLEAR
K
06
0942
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K
05
1620
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
K
04
2018
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K
04
3344
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
K
04
2797
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
04
1884
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
04
2089
NX STAGE WATER PURIFICATION SYSTEM
K
03
1832
MEGA PURE CART
K
04
1163
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K
03
3648
PERFORMANCE WATER TREATMENT SYSTEM
K
03
0348
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
K
03
2004
AQUABOSS ECORO DIA 50
K
03
0652
MEDRO SPD
K
02
1560
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
02
2448
WATER PURIFICATION SYSTEM
K
03
0059
PORTABLE RO+ MODEL MROS09
K
02
2747
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
K
01
1005
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K
00
1755
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K
02
1352
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K
01
3677
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K
01
4169
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K
00
3957
DIACLEAR ULTRAFILTER
K
01
0592
AQUA WATER TREATMENT FOR HEMODIALYSIS
K
00
3877
MAR COR SERVICES SEMPER PURE RO MACHINE
K
00
2045
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
99
4292
WATER PURIFICATION SYSTEM
K
99
4279
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K
00
1282
AIW WATER SYSTEM FOR HEMODIALYSIS
K
00
0249
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
K
00
1811
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K
99
1495
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
K
99
3806
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K
99
3877
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K
99
3520
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
99
1519
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
99
3200
MD 420/440/460/470/480/490
K
99
2786
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K
99
1916
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
98
3239
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
K
98
3512
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K
98
3126
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K
98
1680
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K
98
0182
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
97
4899
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K
98
1085
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K
97
4127
HYDRA METER
K
96
4539
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
K
94
5559
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K
94
4493
REVERSE OSMOSIS SYSTEM
K
95
4928
PORTABLE REVERSE OSMOSIS MACHINE
K
95
4349
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K
94
5066
AWESMOSIS
K
94
4767
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K
92
4695
ASEPTECH PORTABLE RO+ SYSTEM
K
95
2215
SERIM HISENSE TEST KIT
K
92
0186
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K
94
4385
MD400 A/B/C/D/E/F/G
K
94
5136
RENAGUARD DIALYSATE FILTER
K
93
1595
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
K
93
4848
MASTER ALERT
K
91
5258
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
K
89
4300
SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
K
89
4106
DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
K
87
1242
REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K
87
3487
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES
K
86
3720
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
K
84
2215
ASCORBIC ACID
K
84
1403
HEMO-RO WATER PURIFICATION SYS
K
82
2385
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K
81
1678
GAMBRO WATER PURIFICATION MONITOR WRD
K
80
2474
CMR 300, ROWATER TREATMENT UNIT
K
80
0305
WATER CONDUCTIVITY MONITOR & CONTROLLER
K
79
1086
CENTRY 2 SYSTEM #016, 103, 016, 104
K
77
1763
HEMO-RO
FIQ
Cannula, A-V Shunt
FIR
Pump, Blood, Extra-Luminal
FIS
Flowmeter, Dialysate
FIW
Alarm, Pillow Pressure
FIZ
Meter, Conductivity, Non-Remote
FJA
Manometer, Water
FJB
Detector, Dialysate Level
FJC
Detector, Blood Level
FJD
Detector, Leak, Blood
FJF
Detector, Air Bubble
FJG
Dialyzer, Parallel Flow
FJH
Dialyzer, Disposable
FJI
Dialyzer, Capillary, Hollow Fiber
FJJ
Dialyzer, Twin Coil
FJK
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
FJM
Guard, Shunt
FJN
Stabilizer, Shunt
FJO
Plier, Tube
FJP
Adaptor, Y
FJQ
Connector, Shunt
FJR
Forceps, Disconnect
FJS
Catheter, Peritoneal, Long-Term Indwelling
FJT
Intracatheter, Dialysis
FJW
Ring, Joint
FJX
Ring, Crimp
FJY
Plier, Crimp
FJZ
Declotting Tray, Kit (Including Contents)
FKA
Dilator, Vessel
FKB
Connector, Blood Tubing, Infusion T
FKC
Clamp, Cannula
FKD
Canister, Coil
FKE
Tie, Dialysis
FKF
Gun, Tie, Dialysis
FKG
Tray, Start/Stop (Including Contents), Dialysis
FKH
Solution-Test Standard-Conductivity, Dialysis
FKI
Set, Dialyzer Holder
FKJ
Filter, Blood, Dialysis
FKL
Insert, Pump, Blood
FKM
Adaptor, Fistula
FKN
Adaptor, Shunt
FKO
Catheter, Peritoneal Dialysis, Single Use
FKP
System, Dialysate Delivery, Single Patient
FKQ
System, Dialysate Delivery, Central Multiple Patient
FKR
Subsystem, Proportioning
FKT
System, Dialysate Delivery, Sorbent Regenerated
FKW
Tip, Vessel
FKX
System, Peritoneal, Automatic Delivery
FKY
Connector, Tubing, Dialysate
FLA
Monitor, Temperature, Dialysis
FLB
Meter, Conductivity, Induction, Remote Type
FLC
Station, Dialysis Control, Negative Pressure Type
FLD
Apparatus, Hemoperfusion, Sorbent
FOC
Bag, Urine Collection, Newborn
FON
Bag, Drainage, With Adhesive, Ostomy
FPD
Tube, Feeding
FRQ
Tube, Levine
GBL
Catheter, Ureteral, General & Plastic Surgery
GBM
Catheter, Urethral
GBT
Catheter, Rectal
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
GDS
Bag, Stomal
KDH
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
KDK
Container, Transport, Kidney
KDL
Set, Perfusion, Kidney, Disposable
KDN
System, Perfusion, Kidney
KGC
Tube, Gastro-Enterostomy
KNQ
Dilator, Esophageal
KNR
Adapter, A-V Shunt Or Fistula
KNT
Tubes, Gastrointestinal (And Accessories)
KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
KNY
Accessories, Catheter, G-U
KNZ
Accessories, A-V Shunt
KOB
Catheter, Suprapubic (And Accessories)
KOC
Accessories, Blood Circuit, Hemodialysis
KOD
Catheter, Urological
KOE
Dilator, Urethral
KPF
System, Dialysate Delivery, Semi-Automatic, Peritoneal
KPH
Catheter, Rectal For Continent Ileostomy
KPI
Stimulator, Electrical, Non-Implantable, For Incontinence
KPL
Colonic Irrigation System
KPM
Shunt, Peritoneal
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
KPP
Peritoneal Dialysate Filter
KQQ
Tubing, Dialysate (And Connector)
KQR
Detector, Air Or Foam
KXM
System Accessories, Extracorporeal
LBW
Set, Dialysis, Single Needle (Co-Axial Flow)
LCG
Intestinal Splinting Tubes
LFJ
Catheter, Subclavian
LFK
Catheter, Femoral
LIF
Dialyzer Reprocessing System
LJH
System, Irrigation, Urological
LKY
Device, External Penile Rigidity
LLB
System, Blood, Extracorporeal And Accessories
LNS
Lithotriptor, Extracorporeal Shock-Wave, Urological
LQR
Dislodger, Stone, Biliary
LRI
Ph Meter For Dialysis Hydrogen Ion Concentration
MJC
Catheter, Urological (Antimicrobial) And Accessories
MLW
Warmer, Peritoneal Dialysate
MNG
External Urethral Occluder, Urinary Incontinence-Control, Female
MNV
Strip, Dialysate Ph Indicator
MON
System, Hemodialysis, Remote Accessories
MPB
Catheter, Hemodialysis, Non-Implanted
MQS
System, Hemodialysis, Access Recirculation Monitoring
MSB
System And Accessories, Isolated Heart, Transport And Preservation
MSD
Catheter, Hemodialysis, Implanted
MSE
Hemodialyzer, Re-Use, Low Flux
MSF
Hemodialyzer, Re-Use, High Flux
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
MSZ
Strip, Test, Reagent, Residuals For Dialysate
NAM
Stimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction
NDS
Media, Culture, Ex Vivo, Tissue And Cell
NFK
Kit, Repair, Catheter, Hemodialysis
NHV
System, Water Purification, General Medical Use
NIE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
NIF
Catheter, Hemodialysis, Triple Lumen, Implanted
NML
Catheter, Biliary, Reprocessed
NNE
Needle, Fistula, Reprocessed
NNG
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed
NNW
Bag, Urine Collection, Leg, For External Use, Non-Sterile
NNX
Device, Incontinence, Urosheath Type, Non-Sterile
NNY
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
NNZ
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
NOA
Device, Paste-On For Incontinence, Non-Sterile
NOO
Clamp, Dialysis Arm
NOY
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
NQJ
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
NTZ
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
NUB
Colonic Irrigation System, General Well Being
NYU
Catheter, Hemodialysis, Implanted, Coated
NWO
Kit, Catheter, Urinary (Exludes Hiv Testing)
NWP
Suprapubic Cystostomy Catheter Kit
NWQ
Kit, Catheter, External, Male (Excludes Hiv Testing)
NWR
Kit, Catheter, Foley (Excludes Hiv Testing)
NZU
Collector, Urine, Powered, Non Indwelling Catheter
ODN
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
ODX
Autonomous Extracorporeal Blood Leak Detector/Alarm
OHR
Catheter Care Tray
ONW
Hemodialysis System For Home Use
ONY
Oral Removable Retainer For Weight Management
PBP
Rectal Insert
PCU
Pancreatic Stent, Covered, Metallic, Removable
PEH
Hemodialysis Catheter Luer End Cap
PEV
Dialysis Administration Kit
PEW
Implantable Transprostatic Tissue Retractor System
PFH
Venous Window Needle Guide
PIA
Vibrator For Climax Control Of Premature Ejaculation
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
PIE
Esophageal Dilator With Balloon And Electrode Sensors
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
QGC
Suprapubic Catheter Accessories
PIH
Urethral Insert With Pump For Bladder Drainage
PIN
Kidney Perfusion Kit
PIO
Enteral Specific Transition Connectors
PJH
Dynamic Rectal Control System
PKI
Fully Subcutaneous Implanted Hemodialysis Catheter
PLI
Gastrointestional Tube Holder
PLQ
Enzyme Packed Cartridge
PNB
Biliary Stent System For Benign Strictures
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
PNR
Enteral Syringes With Enteral Specific Connectors
QFQ
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
PPA
Bladder Irrigation Kit
PPB
Foley Catheter Kit (Excludes Hiv Testing)
PPC
Male External Catheterization Kit (Excludes Hiv Testing)
PPD
Universal Drainage Tray
PPF
Urinary Irrigation Kit
PPG
Urinary Drainage Collection Kit
PPH
Single Needle With Uni-Directional Pump Kit
PPI
Hemodialysis Tray (Not A Start/Stop Kit)
PPJ
Peritoneal Dialysis Administration Kit
PPK
Peritoneal Dialysis Tubing Kit
PPL
Single Needle (Co-Axial Flow) Dialysis Kit
PPO
Multi-Lumen Hemodialysis Catheterization Kit
PQE
Ostomy Care Kit
PRM
Enteral Administration Kit (Adult & Pediatric)
PRO
Anti-Regurgitation Blood Tubing Kit
PRP
Balloon Gastrostomy Tube Kit
PRQ
Esophageal Dilator Kit
PRR
Feeding Tube Kit
PRS
Gastric Colonic Catheter Irrigation Kit
PRT
Gastric Irrigation And Aspiration Kit
PRW
Gastrointestinal Tube Kit
PRX
Gastrostomy Guide Wire Placement Kit
PRY
Gastrostomy Jejunostomy Feeding Tube Kit
PRZ
Gastrostomy Tube Kit
PSA
Laparoscopic Jejunostomy Kit
PSB
Nasogastric Feed Tube Kit
PSC
Nasogastric-Gastrojejunal Kit
PSD
Laparoscopic Gastrostomy Kit
PSE
Needle Catheter Jejunostomy Kit
PSF
Non-Balloon Replacement Gastrostomy System
PSG
Percutaneous Endoscopic Gastrostomy Kit
PSH
Percutaneous Replacement Gastrostomy Tube Kit
PSJ
Rectal Dilator Kit
PSK
Replacement Gastrostomy Feeding Catheter Tray
PSX
Chlorine Meter
PTK
Pediatric Esophageal Atresia Anastomosis Device
PTT
Biliary Catheter For Irrigation And Contrast Injection, Exempt
PTU
Catheter, Peritoneal, Long-Term Indwelling, Exempt
PTV
Catheter, Peritoneal Dialysis, Single Use, Exempt
PTW
System, Peritoneal, Automatic Delivery, Exempt
QAJ
Cutaneous Electrode Stimulator For Urinary Incontinence
QGD
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
QGE
Biliary Stent, Drain, And Dilator Accessories
QON
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
QRC
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
therapeutic-devices
/
FIP
/
K121022
View Source
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121022
510(k) Type
Traditional
Applicant
AMERIWATER
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/17/2012
Days to Decision
166 days
Submission Type
Summary