FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
K
23
3707
HFT150
2
Cleared 510(K)
K
23
3821
F&P Optiflow Oxygen Kit (AA451J)
2
Cleared 510(K)
K
22
2292
F&P myAirvo 3
2
Cleared 510(K)
K
23
1956
F&P Optiflow+ Duet Nasal Cannula
2
Cleared 510(K)
K
23
0559
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
2
Cleared 510(K)
K
22
3863
BONHAWA Respiratory Humidifier
2
Cleared 510(K)
K
22
3684
F&P 820 Humidification System
2
Cleared 510(K)
K
23
1380
AirLife DuoTherm™ Humidification System
2
Cleared 510(K)
K
22
3551
Sterile Water for Inhalation in 1L Flexoval ® bottles.
2
Cleared 510(K)
K
22
0703
F&P 950 Respiratory Humidifier
2
Cleared 510(K)
K
22
2197
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
2
Cleared 510(K)
K
22
2351
inspired™ VHB20 Heated Humidifier
2
Cleared 510(K)
K
21
2031
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
2
Cleared 510(K)
K
21
1096
Optiflow Oxygen Kit
2
Cleared 510(K)
K
20
3357
HVT 2.0
2
Cleared 510(K)
K
20
1723
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
2
Cleared 510(K)
K
19
3411
O2asis Personal Oxygen Humidifier
2
Cleared 510(K)
K
19
1818
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
2
Cleared 510(K)
K
19
1010
Palladium High Flow Therapy System
2
Cleared 510(K)
K
16
2553
AirSpiral Heated Breathing Tube
2
Cleared 510(K)
K
18
0474
TNI softFlow 50
2
Cleared 510(K)
K
16
1719
Salter Labs Bubble Humidifier
2
Cleared 510(K)
K
16
3283
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
2
Cleared 510(K)
K
16
2242
Comfort Flo Humidification System
2
Cleared 510(K)
K
16
0764
AirLife Autofill Humidification Chamber
2
Cleared 510(K)
K
16
1314
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
2
Cleared 510(K)
K
15
2029
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
2
Cleared 510(K)
K
14
3646
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
2
Cleared 510(K)
K
14
1940
CONCHASMART COLUMN
2
Cleared 510(K)
K
13
3766
HUMICARE D900
2
Cleared 510(K)
K
14
0556
CONCHASMART BREATHING CIRCUIT
2
Cleared 510(K)
K
14
1353
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
2
Cleared 510(K)
K
13
2857
RESPIRATORY GAS HUMIDIFIER
2
Cleared 510(K)
K
13
2017
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
2
Cleared 510(K)
K
13
1912
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
2
Cleared 510(K)
K
13
1957
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
2
Cleared 510(K)
K
13
1895
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
2
Cleared 510(K)
K
13
1388
TRANSCEND HEATED HUMIDIFIER
2
Cleared 510(K)
K
12
2885
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
2
Cleared 510(K)
K
12
2705
HUMICARE D900
2
Cleared 510(K)
K
12
1975
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
2
Cleared 510(K)
K
11
0019
RESPIRATORY HUMIDIFER
2
Cleared 510(K)
K
11
3542
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
2
Cleared 510(K)
K
11
1640
PRECISION FLOW(R) - HELIOX
2
Cleared 510(K)
K
10
3316
FLOWREST
2
Cleared 510(K)
K
09
3617
VENTLAB 6000 SERIES HUMIDIFIER
2
Cleared 510(K)
K
10
2618
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
2
Cleared 510(K)
K
09
2256
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
2
Cleared 510(K)
K
10
0554
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
2
Cleared 510(K)
K
09
2846
AIRVO SERIES HUMIDIFIERS
2
Cleared 510(K)
K
09
0915
STERILE WATER FOR INHALATION FLEX BAG, USP
2
Cleared 510(K)
K
08
0149
HEATER BASE, MODEL PMH7000
2
Cleared 510(K)
K
07
2845
PRECISION FLOW
2
Cleared 510(K)
K
08
0797
HUMIDAIRE 2I
2
Cleared 510(K)
K
07
3706
RESPIRATORY HUMIDIFIER, MODEL MR850
2
Cleared 510(K)
K
07
2982
PARI HYDRATE V
2
Cleared 510(K)
K
07
1958
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
2
Cleared 510(K)
K
07
0714
MEDISIZE GOLD HEATER AND BOOSTER
2
Cleared 510(K)
K
06
3758
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
2
Cleared 510(K)
K
07
0056
VAPOTHERM MODEL# 2000I AND 2000H
2
Cleared 510(K)
K
07
0107
PARI HYDRATE G
2
Cleared 510(K)
K
06
2664
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
2
Cleared 510(K)
K
06
1736
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
2
Cleared 510(K)
K
06
2091
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
2
Cleared 510(K)
K
06
0790
BREAS, MODEL HA01
2
Cleared 510(K)
K
05
2615
MEDISIZE GOLD
2
Cleared 510(K)
K
05
0990
REMREST HEATED HUMIDIFIER
2
Cleared 510(K)
K
05
0314
AQUINOX
2
Cleared 510(K)
K
04
2184
GOODKNIGHT H20, MODEL M-114600-00
2
Cleared 510(K)
K
04
1963
AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
2
Cleared 510(K)
K
04
2245
VAPOTHERM MODEL#2000I, 200H
2
Cleared 510(K)
K
02
0700
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
2
Cleared 510(K)
K
03
3710
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
2
Cleared 510(K)
K
03
1176
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
2
Cleared 510(K)
K
04
0507
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
2
Cleared 510(K)
K
03
1179
TAGA VELOCITY HUMIDIFIER
2
Cleared 510(K)
K
03
1383
MODEL 780
2
Cleared 510(K)
K
02
0332
RESPIRATORY HUMIDIFIER, MODEL MR850
2
Cleared 510(K)
K
01
3486
VAPOTHERM 2000H
2
Cleared 510(K)
K
01
3856
PMH 1000 HEATED HUMIDIFIER
2
Cleared 510(K)
K
03
0090
H2 HEATED HUMIDIFIER
2
Cleared 510(K)
K
02
0900
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
2
Cleared 510(K)
K
01
2633
RESPIRONICS HEATED HUMIDIFIER
2
Cleared 510(K)
K
00
3973
RESPIRATORY HUMIDIFIER, MODEL HC150
2
Cleared 510(K)
K
00
3626
DEVILBISS HUMIDIFIER
2
Cleared 510(K)
K
01
0578
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
2
Cleared 510(K)
K
00
3561
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
2
Cleared 510(K)
K
01
0402
SMOOTH-FLO CIRCUIT
2
Cleared 510(K)
K
00
2454
BREAS HA50 HUMIDIFIER, MODEL HA50
2
Cleared 510(K)
K
00
1213
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
2
Cleared 510(K)
K
98
3783
HEATED HUMIDIFIER
2
Cleared 510(K)
K
99
3282
IPI HUMIDIFIER CHAMBER
2
Cleared 510(K)
K
99
3773
HUMID-HEAT
2
Cleared 510(K)
K
00
0401
VAPOTHERM, MODEL 2000I
2
Cleared 510(K)
K
99
3355
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
2
Cleared 510(K)
K
99
0614
HME-BOOSTER
2
Cleared 510(K)
K
99
3268
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
2
Cleared 510(K)
K
98
3862
CLOUD 1 HUMIDIFICATION SYSTEM
2
Cleared 510(K)
K
99
1484
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
2
Cleared 510(K)
K
98
3112
RESPIRATORY HUMIDIFIER, MODEL # MR850
2
Cleared 510(K)
K
97
1260
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
2
Cleared 510(K)
K
97
0478
SCT 3000 HEATED HUMIDIFIER
2
Cleared 510(K)
K
96
4653
OASIS HUMIDIFIER
2
Cleared 510(K)
K
96
2223
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
2
Cleared 510(K)
K
96
3025
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
2
Cleared 510(K)
K
96
2079
HUMIDIFIER ADAPTER
2
Cleared 510(K)
K
95
3392
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
2
Cleared 510(K)
K
94
5782
HUMIDIFIER
2
Cleared 510(K)
K
95
0582
SULLIVAN PASSOVER HUMIDIFER
2
Cleared 510(K)
K
92
3946
CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
2
Cleared 510(K)
K
93
6000
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
2
Cleared 510(K)
K
93
4140
MR290 HUMIDIFICATION CHAMBER SINGLE USE
2
Cleared 510(K)
K
92
6161
RES Q AIR SYSTEM MODEL HT-1000
2
Cleared 510(K)
K
93
2570
MARK I HUMIDIFIER
2
Cleared 510(K)
K
91
5460
HEATED RESPIRATORY HUMIDIFIER HC100
2
Cleared 510(K)
K
92
3754
MISTY OX LAMINAR DIFFUSER HUMIDIFIER
2
Cleared 510(K)
K
91
3367
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS
2
Cleared 510(K)
K
91
5890
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
2
Cleared 510(K)
K
91
4686
THERMO-FLOW SET
2
Cleared 510(K)
K
92
0306
OPTI-MOL FILTERED PUNCTURE PIN
2
Cleared 510(K)
K
91
3368
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
2
Cleared 510(K)
K
91
1770
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
2
Cleared 510(K)
K
90
3138
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
2
Cleared 510(K)
K
90
2970
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
2
Cleared 510(K)
K
90
1762
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
2
Cleared 510(K)
K
90
0854
JOHN BUNN: MEDIX COMPACT TRAVELLER
2
Cleared 510(K)
K
90
0602
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
2
Cleared 510(K)
K
90
0569
THERMOPROBE 210
2
Cleared 510(K)
K
89
6315
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
2
Cleared 510(K)
K
89
2817
HEATED RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
89
3122
HEATED SERVO HUMIDIFIER, MODEL HDS 2
2
Cleared 510(K)
K
89
4000
THERA-MIST HUMIDIFIER
2
Cleared 510(K)
K
89
3034
VHS 820 HUMIDIFIER, MODIFICATION
2
Cleared 510(K)
K
88
1970
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
88
5314
HPD STERILE HUMIDIFYING CHAMBER
2
Cleared 510(K)
K
88
4150
MODIFIED CONCHATHERM III CONTROLLED HEATER
2
Cleared 510(K)
K
88
2582
STERILE INHALATION WATER TRANSFER SET
2
Cleared 510(K)
K
88
0979
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
2
Cleared 510(K)
K
88
0702
MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES
2
Cleared 510(K)
K
88
1184
INTERTECH STERILE WATER FOR INHALATION
2
Cleared 510(K)
K
87
4659
STERILIZATION OF DEVICES BY RADIATION
2
Cleared 510(K)
K
87
3472
MEMBRANE HUMIDIFIER
2
Cleared 510(K)
K
87
3634
BEAR VH-820 HUMIDIFIER
2
Cleared 510(K)
K
87
2138
MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
2
Cleared 510(K)
K
87
2139
MR420 TRANSPORT HUMIDIFIER
2
Cleared 510(K)
K
87
1618
PREFILLED STERILE WATER FOR INHALATION, USP
2
Cleared 510(K)
K
87
0173
LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL
2
Cleared 510(K)
K
86
3377
MR338 SERVO HEATED DELIVERY HUMIDIFIER
2
Cleared 510(K)
K
87
0055
MR590 DUAL HOSE HEATER POWER PACK
2
Cleared 510(K)
K
86
4173
HPD HUMIDIFYING CHAMBER
2
Cleared 510(K)
K
86
3154
HEATED JET HUMIDIFIER MODEL AMS-1020
2
Cleared 510(K)
K
86
3955
COLBY LEVEL ALARM
2
Cleared 510(K)
K
86
2923
MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
2
Cleared 510(K)
K
85
4363
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
2
Cleared 510(K)
K
85
1879
HEATED RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
85
3146
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
2
Cleared 510(K)
K
85
1940
STERILE WATER FOR INHALATION USP 2D0799
2
Cleared 510(K)
K
85
0647
HEATED RESPIRATORY HUMIFIFIER MR440
2
Cleared 510(K)
K
84
3903
HEATED RESPIRATORY HUMIDIFIER MR428
2
Cleared 510(K)
K
84
3932
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
2
Cleared 510(K)
K
84
2795
MAXI-MISER HUMIDIFIER INSERT 1030
2
Cleared 510(K)
K
84
2794
MAXI-MISER HUMIDIFIER INSERT 1020 & 1021
2
Cleared 510(K)
K
84
1295
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
2
Cleared 510(K)
K
84
2340
VH820 HUMIDIFIER
2
Cleared 510(K)
K
84
2523
BIRD HEATED HUMIDIFIER 3201
2
Cleared 510(K)
K
84
1851
HPD HUMIDIFIER WICK
2
Cleared 510(K)
K
84
1158
NEBULO 28 NEBULIZER KIT
2
Cleared 510(K)
K
83
4151
CONCHATHERM LHF HUMIDIFIER HEATER
2
Cleared 510(K)
K
83
3974
AQUAPAK 020 HUMIDIFIER ADAPTER
2
Cleared 510(K)
K
83
2928
SERVO HEATED RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
83
1556
VAPOR-PHASE HUMIDIFIER SYSTEM
2
Cleared 510(K)
K
83
0913
MINITROP AEROSAL, PRODOMO AEROSAL AND
2
Cleared 510(K)
K
83
1163
LO-COMP RESERVOIR-RE-1000
2
Cleared 510(K)
K
82
3143
BUBBLE HUMIDIFIERS
2
Cleared 510(K)
K
82
2816
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
82
0878
CONCHO PEDIATRIC PACK
2
Cleared 510(K)
K
81
2957
EAST AUTOCLAVE HUMIDIFIER
2
Cleared 510(K)
K
81
1073
A QUAPAK
2
Cleared 510(K)
K
81
0939
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
2
Cleared 510(K)
K
81
0559
OPTI- SYSTEM
2
Cleared 510(K)
K
81
0219
PREFILLED HUMIDIFER
2
Cleared 510(K)
K
80
2852
HUMIDIFIER
2
Cleared 510(K)
K
80
2145
2C 7140 HEATED HUMIDIFER CANNISTER
2
Cleared 510(K)
K
80
2144
2M8101 HEATED LIQUID LEVEL CONTROLLER
2
Cleared 510(K)
K
80
1619
MIST2GEN TEMPTROL 10
2
Cleared 510(K)
K
80
1252
NEBULIZER WITH AIR ENTERTAINER & ETC.
2
Cleared 510(K)
K
80
0753
STERILE WATER & SALINE IN PLASTIC BTL.
2
Cleared 510(K)
K
79
2620
NEONATAL HEATED HUMIDIFIER
2
Cleared 510(K)
K
80
0056
VENTILATOR SET
2
Cleared 510(K)
K
79
1683
STERILE WATER FOR RESPIRATORY THERAPY
2
Cleared 510(K)
K
79
0731
OXYGEN HUMIDIFIER KIT
2
Cleared 510(K)
K
78
1760
HUMIDIFIERS, MODEL:LS-420 AND LS-460
2
Cleared 510(K)
K
78
1600
MISTY-OX PREFILLED HUMIDIFIER, DISP.
2
Cleared 510(K)
K
78
1537
NEBULIZER/HUMIDIFIER
2
Cleared 510(K)
K
78
1468
CONTINUOUS FEED VALVE 2D9024
2
Cleared 510(K)
K
78
0845
CONCHANEOPAK A CARTRIDGE HUMIDIFIER
2
Cleared 510(K)
K
78
0385
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
2
Cleared 510(K)
K
78
0381
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
2
Cleared 510(K)
K
78
0562
AQUAPAK PREFILLED HUMIDIFIER
2
Cleared 510(K)
K
78
0088
HYMIDIFIER
2
Cleared 510(K)
K
77
0415
HUMIDIFIER, DISPOSABLE
2
Cleared 510(K)
K
77
0249
VENTILATOR SET - CODE 2C7109
2
Cleared 510(K)
K
76
1293
RESPIRATORY HUMIDIFIER
2
Cleared 510(K)
K
76
0923
HUMIDIFIER-CASCADE II
2
Cleared 510(K)
K
76
0938
DISPOSABLE HUMIDIFIER
2
Cleared 510(K)
K
76
0866
CONCHA-COLUMN
2
Cleared 510(K)
K
76
0584
U-MID PREFILLED HUMIDIFIER (500CC)
2
Cleared 510(K)
K
76
0587
U-MID PREFILLED HUMIDIFIER (300CC)
2
Cleared 510(K)
K
76
0566
PREFILLED HUMIDIFIER
2
Cleared 510(K)
K
76
0372
HUMIDIFIER, DISPOSABLE
2
Cleared 510(K)
K
76
0037
HEATER, IMMERSION W/ HUMIDIFIER & NEBUL.
2
Cleared 510(K)
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BTT
/
K193411
View Source
O2asis Personal Oxygen Humidifier
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193411
510(k) Type
Traditional
Applicant
Perma Pure LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/12/2020
Days to Decision
339 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
K
23
3707
HFT150
K
23
3821
F&P Optiflow Oxygen Kit (AA451J)
K
22
2292
F&P myAirvo 3
K
23
1956
F&P Optiflow+ Duet Nasal Cannula
K
23
0559
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
K
22
3863
BONHAWA Respiratory Humidifier
K
22
3684
F&P 820 Humidification System
K
23
1380
AirLife DuoTherm™ Humidification System
K
22
3551
Sterile Water for Inhalation in 1L Flexoval ® bottles.
K
22
0703
F&P 950 Respiratory Humidifier
K
22
2197
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
K
22
2351
inspired™ VHB20 Heated Humidifier
K
21
2031
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K
21
1096
Optiflow Oxygen Kit
K
20
3357
HVT 2.0
K
20
1723
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
K
19
3411
O2asis Personal Oxygen Humidifier
K
19
1818
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K
19
1010
Palladium High Flow Therapy System
K
16
2553
AirSpiral Heated Breathing Tube
K
18
0474
TNI softFlow 50
K
16
1719
Salter Labs Bubble Humidifier
K
16
3283
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K
16
2242
Comfort Flo Humidification System
K
16
0764
AirLife Autofill Humidification Chamber
K
16
1314
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
K
15
2029
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
K
14
3646
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
K
14
1940
CONCHASMART COLUMN
K
13
3766
HUMICARE D900
K
14
0556
CONCHASMART BREATHING CIRCUIT
K
14
1353
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K
13
2857
RESPIRATORY GAS HUMIDIFIER
K
13
2017
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K
13
1912
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
K
13
1957
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
K
13
1895
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K
13
1388
TRANSCEND HEATED HUMIDIFIER
K
12
2885
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
K
12
2705
HUMICARE D900
K
12
1975
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K
11
0019
RESPIRATORY HUMIDIFER
K
11
3542
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
K
11
1640
PRECISION FLOW(R) - HELIOX
K
10
3316
FLOWREST
K
09
3617
VENTLAB 6000 SERIES HUMIDIFIER
K
10
2618
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
K
09
2256
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K
10
0554
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
K
09
2846
AIRVO SERIES HUMIDIFIERS
K
09
0915
STERILE WATER FOR INHALATION FLEX BAG, USP
K
08
0149
HEATER BASE, MODEL PMH7000
K
07
2845
PRECISION FLOW
K
08
0797
HUMIDAIRE 2I
K
07
3706
RESPIRATORY HUMIDIFIER, MODEL MR850
K
07
2982
PARI HYDRATE V
K
07
1958
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
K
07
0714
MEDISIZE GOLD HEATER AND BOOSTER
K
06
3758
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
K
07
0056
VAPOTHERM MODEL# 2000I AND 2000H
K
07
0107
PARI HYDRATE G
K
06
2664
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
K
06
1736
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
K
06
2091
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
K
06
0790
BREAS, MODEL HA01
K
05
2615
MEDISIZE GOLD
K
05
0990
REMREST HEATED HUMIDIFIER
K
05
0314
AQUINOX
K
04
2184
GOODKNIGHT H20, MODEL M-114600-00
K
04
1963
AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
K
04
2245
VAPOTHERM MODEL#2000I, 200H
K
02
0700
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
K
03
3710
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
K
03
1176
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K
04
0507
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
K
03
1179
TAGA VELOCITY HUMIDIFIER
K
03
1383
MODEL 780
K
02
0332
RESPIRATORY HUMIDIFIER, MODEL MR850
K
01
3486
VAPOTHERM 2000H
K
01
3856
PMH 1000 HEATED HUMIDIFIER
K
03
0090
H2 HEATED HUMIDIFIER
K
02
0900
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
K
01
2633
RESPIRONICS HEATED HUMIDIFIER
K
00
3973
RESPIRATORY HUMIDIFIER, MODEL HC150
K
00
3626
DEVILBISS HUMIDIFIER
K
01
0578
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
K
00
3561
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K
01
0402
SMOOTH-FLO CIRCUIT
K
00
2454
BREAS HA50 HUMIDIFIER, MODEL HA50
K
00
1213
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
K
98
3783
HEATED HUMIDIFIER
K
99
3282
IPI HUMIDIFIER CHAMBER
K
99
3773
HUMID-HEAT
K
00
0401
VAPOTHERM, MODEL 2000I
K
99
3355
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
K
99
0614
HME-BOOSTER
K
99
3268
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
K
98
3862
CLOUD 1 HUMIDIFICATION SYSTEM
K
99
1484
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K
98
3112
RESPIRATORY HUMIDIFIER, MODEL # MR850
K
97
1260
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K
97
0478
SCT 3000 HEATED HUMIDIFIER
K
96
4653
OASIS HUMIDIFIER
K
96
2223
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K
96
3025
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K
96
2079
HUMIDIFIER ADAPTER
K
95
3392
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
K
94
5782
HUMIDIFIER
K
95
0582
SULLIVAN PASSOVER HUMIDIFER
K
92
3946
CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
K
93
6000
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K
93
4140
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K
92
6161
RES Q AIR SYSTEM MODEL HT-1000
K
93
2570
MARK I HUMIDIFIER
K
91
5460
HEATED RESPIRATORY HUMIDIFIER HC100
K
92
3754
MISTY OX LAMINAR DIFFUSER HUMIDIFIER
K
91
3367
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS
K
91
5890
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
K
91
4686
THERMO-FLOW SET
K
92
0306
OPTI-MOL FILTERED PUNCTURE PIN
K
91
3368
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
K
91
1770
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K
90
3138
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K
90
2970
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K
90
1762
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
K
90
0854
JOHN BUNN: MEDIX COMPACT TRAVELLER
K
90
0602
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K
90
0569
THERMOPROBE 210
K
89
6315
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K
89
2817
HEATED RESPIRATORY HUMIDIFIER
K
89
3122
HEATED SERVO HUMIDIFIER, MODEL HDS 2
K
89
4000
THERA-MIST HUMIDIFIER
K
89
3034
VHS 820 HUMIDIFIER, MODIFICATION
K
88
1970
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K
88
5314
HPD STERILE HUMIDIFYING CHAMBER
K
88
4150
MODIFIED CONCHATHERM III CONTROLLED HEATER
K
88
2582
STERILE INHALATION WATER TRANSFER SET
K
88
0979
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
K
88
0702
MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES
K
88
1184
INTERTECH STERILE WATER FOR INHALATION
K
87
4659
STERILIZATION OF DEVICES BY RADIATION
K
87
3472
MEMBRANE HUMIDIFIER
K
87
3634
BEAR VH-820 HUMIDIFIER
K
87
2138
MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
K
87
2139
MR420 TRANSPORT HUMIDIFIER
K
87
1618
PREFILLED STERILE WATER FOR INHALATION, USP
K
87
0173
LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL
K
86
3377
MR338 SERVO HEATED DELIVERY HUMIDIFIER
K
87
0055
MR590 DUAL HOSE HEATER POWER PACK
K
86
4173
HPD HUMIDIFYING CHAMBER
K
86
3154
HEATED JET HUMIDIFIER MODEL AMS-1020
K
86
3955
COLBY LEVEL ALARM
K
86
2923
MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
K
85
4363
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
K
85
1879
HEATED RESPIRATORY HUMIDIFIER
K
85
3146
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
K
85
1940
STERILE WATER FOR INHALATION USP 2D0799
K
85
0647
HEATED RESPIRATORY HUMIFIFIER MR440
K
84
3903
HEATED RESPIRATORY HUMIDIFIER MR428
K
84
3932
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
K
84
2795
MAXI-MISER HUMIDIFIER INSERT 1030
K
84
2794
MAXI-MISER HUMIDIFIER INSERT 1020 & 1021
K
84
1295
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
K
84
2340
VH820 HUMIDIFIER
K
84
2523
BIRD HEATED HUMIDIFIER 3201
K
84
1851
HPD HUMIDIFIER WICK
K
84
1158
NEBULO 28 NEBULIZER KIT
K
83
4151
CONCHATHERM LHF HUMIDIFIER HEATER
K
83
3974
AQUAPAK 020 HUMIDIFIER ADAPTER
K
83
2928
SERVO HEATED RESPIRATORY HUMIDIFIER
K
83
1556
VAPOR-PHASE HUMIDIFIER SYSTEM
K
83
0913
MINITROP AEROSAL, PRODOMO AEROSAL AND
K
83
1163
LO-COMP RESERVOIR-RE-1000
K
82
3143
BUBBLE HUMIDIFIERS
K
82
2816
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER
K
82
0878
CONCHO PEDIATRIC PACK
K
81
2957
EAST AUTOCLAVE HUMIDIFIER
K
81
1073
A QUAPAK
K
81
0939
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K
81
0559
OPTI- SYSTEM
K
81
0219
PREFILLED HUMIDIFER
K
80
2852
HUMIDIFIER
K
80
2145
2C 7140 HEATED HUMIDIFER CANNISTER
K
80
2144
2M8101 HEATED LIQUID LEVEL CONTROLLER
K
80
1619
MIST2GEN TEMPTROL 10
K
80
1252
NEBULIZER WITH AIR ENTERTAINER & ETC.
K
80
0753
STERILE WATER & SALINE IN PLASTIC BTL.
K
79
2620
NEONATAL HEATED HUMIDIFIER
K
80
0056
VENTILATOR SET
K
79
1683
STERILE WATER FOR RESPIRATORY THERAPY
K
79
0731
OXYGEN HUMIDIFIER KIT
K
78
1760
HUMIDIFIERS, MODEL:LS-420 AND LS-460
K
78
1600
MISTY-OX PREFILLED HUMIDIFIER, DISP.
K
78
1537
NEBULIZER/HUMIDIFIER
K
78
1468
CONTINUOUS FEED VALVE 2D9024
K
78
0845
CONCHANEOPAK A CARTRIDGE HUMIDIFIER
K
78
0385
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K
78
0381
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
K
78
0562
AQUAPAK PREFILLED HUMIDIFIER
K
78
0088
HYMIDIFIER
K
77
0415
HUMIDIFIER, DISPOSABLE
K
77
0249
VENTILATOR SET - CODE 2C7109
K
76
1293
RESPIRATORY HUMIDIFIER
K
76
0923
HUMIDIFIER-CASCADE II
K
76
0938
DISPOSABLE HUMIDIFIER
K
76
0866
CONCHA-COLUMN
K
76
0584
U-MID PREFILLED HUMIDIFIER (500CC)
K
76
0587
U-MID PREFILLED HUMIDIFIER (300CC)
K
76
0566
PREFILLED HUMIDIFIER
K
76
0372
HUMIDIFIER, DISPOSABLE
K
76
0037
HEATER, IMMERSION W/ HUMIDIFIER & NEBUL.
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
BTT
/
K193411
View Source
O2asis Personal Oxygen Humidifier
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193411
510(k) Type
Traditional
Applicant
Perma Pure LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/12/2020
Days to Decision
339 days
Submission Type
Summary