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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
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Dental
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Ear, Nose, Throat
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Gastroenterology and Urology
Review Panel
General Hospital
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—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
BRZ
Set, Blood Transfusion
2
Product Code
BWJ
Locator, Acupuncture Point
2
Product Code
CAK
Microfilter, Blood Transfusion
2
Product Code
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
2
Product Code
FMF
Syringe, Piston
2
Product Code
FMG
Stopcock, I.V. Set
2
Product Code
FMI
Needle, Hypodermic, Single Lumen
2
Product Code
FMS
Bed, Pediatric Open Hospital
2
Product Code
FMT
Warmer, Infant Radiant
2
Product Code
FMZ
Incubator, Neonatal
2
Product Code
FNG
Lift, Patient, Ac-Powered
2
Product Code
FNJ
Bed, Manual
1
Product Code
FNK
Bed, Hydraulic, Adjustable Hospital
1
Product Code
FNL
Bed, Ac-Powered Adjustable Hospital
2
Product Code
FNM
Mattress, Air Flotation, Alternating Pressure
2
Product Code
FNN
Nipple, Lambs Feeding
1
Product Code
FOD
Device, Occlusion, Umbilical
1
Product Code
FOH
Mattress, Water, Temperature Regulated
1
Product Code
FOK
Pad, Neonatal Eye
1
Product Code
FOS
Catheter, Umbilical Artery
2
Product Code
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
2
Product Code
FPA
Set, Administration, Intravascular
2
Product Code
FPB
Filter, Infusion Line
2
Product Code
FPK
Tubing, Fluid Delivery
2
Product Code
FPL
Incubator, Neonatal Transport
2
Product Code
FQH
Lavage, Jet
2
Product Code
FQJ
Support, Scrotal, Therapeutic
1
Product Code
FQK
Binder, Perineal
1
Product Code
FQL
Stocking, Medical Support (For General Medical Purposes)
1
Product Code
FQM
Bandage, Elastic
1
Product Code
FRF
Cleaner, Air, Medical Recirculating
2
Product Code
FRL
Fiber, Medical, Absorbent
1
Product Code
FRN
Pump, Infusion
2
Product Code
FRP
Holder, Infant Position
1
Product Code
FRR
Chamber, Reverse Isolation, Patient Care
2
Product Code
FSA
Lift, Patient, Non-Ac-Powered
1
Product Code
FSD
Binder, Abdominal
1
Product Code
HEF
Binder, Breast
1
Product Code
HFS
Shield, Nipple
1
Product Code
IKY
Mattress, Flotation Therapy, Non-Powered
1
Product Code
KMK
Device, Intravascular Catheter Securement
1
Product Code
KMO
Binder, Elastic
1
Product Code
KPE
Container, I.V.
2
Product Code
KYP
Snake Bite Suction Kit
1
Product Code
KYQ
Kit, Chemical Snake-Bite
3
Product Code
KZD
Infusor, Pressure, For I.V. Bags
1
Product Code
KZE
Injector, Fluid, Non-Electrically Powered
2
Product Code
LBI
Unit, Neonatal Phototherapy
2
Product Code
LDR
Controller, Infusion, Intravascular, Electronic
2
Product Code
LGM
Chamber, Patient Isolation
2
Product Code
LGN
Chamber, Patient Transport Isolation
2
Product Code
LGZ
Warmer, Thermal, Infusion Fluid
2
Product Code
LHF
Warmer, Microwave, Infusion Fluid
2
Product Code
LHI
Set, I.V. Fluid Transfer
2
Product Code
LJL
Detectors And Removers, Lice, (Including Combs)
1
Product Code
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
2
Product Code
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
2
Product Code
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
2
Product Code
LLK
Legging, Compression, Non-Inflatable
2
Product Code
LZH
Pump, Infusion, Enteral
2
Product Code
MDR
Binder, Medical, Therapeutic
1
Product Code
MEA
Pump, Infusion, Pca
2
Product Code
K
16
2165
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
2
Cleared 510(K)
K
17
0982
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
2
Cleared 510(K)
K
14
3612
LifeCare PCA Infusion System
2
Cleared 510(K)
K
13
0394
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
2
Cleared 510(K)
K
09
2313
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
2
Cleared 510(K)
K
07
2144
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
2
Cleared 510(K)
K
05
1253
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
2
Cleared 510(K)
K
04
3299
MEDLEY PCA MODULE, MODEL 8120
2
Cleared 510(K)
K
04
3256
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
2
Cleared 510(K)
K
04
2800
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
2
Cleared 510(K)
K
03
3054
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
2
Cleared 510(K)
K
03
2233
MEDLEY PCA MODULE, MODEL 8120
2
Cleared 510(K)
K
03
1566
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
2
Cleared 510(K)
K
03
0661
STRYKER PAINPUMP2
2
Cleared 510(K)
K
02
0418
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
2
Cleared 510(K)
K
02
0421
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
2
Cleared 510(K)
K
02
2203
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
2
Cleared 510(K)
K
01
3822
MICROJET CRONO PCA
2
Cleared 510(K)
K
00
2739
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
2
Cleared 510(K)
K
00
2434
PALM PUMP
2
Cleared 510(K)
K
99
0312
AVIA PAIN MEDICATION DELIVERY SYSTEM
2
Cleared 510(K)
K
98
2839
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
2
Cleared 510(K)
K
94
3310
MODEL 6100 AMBULATORY INFUSION SYSTEM
2
Cleared 510(K)
K
93
4551
VERIFUSE AMBULATORY PUMP
2
Cleared 510(K)
K
92
0637
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
2
Cleared 510(K)
K
91
5270
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
2
Cleared 510(K)
K
92
1994
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
2
Cleared 510(K)
K
91
5063
IVAC PC ANIFUSER
2
Cleared 510(K)
K
91
4502
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
2
Cleared 510(K)
K
91
0257
BAXA PCA INFUSOR
2
Cleared 510(K)
K
91
1791
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
2
Cleared 510(K)
MEB
Pump, Infusion, Elastomeric
2
Product Code
MEG
Syringe, Antistick
2
Product Code
MHC
Needle, Interosseous
2
Product Code
MHD
Pump, Infusion, Gallstone Dissolution
2
Product Code
MJF
Check Valve, Retrograde Flow (In-Line)
2
Product Code
MMK
Container, Sharps
2
Product Code
MQX
Needle, Acupuncture, Single Use
2
Product Code
MRZ
Accessories, Pump, Infusion
2
Product Code
MZR
Topical Approximation System
1
Product Code
NEP
System/Device, Pharmacy Compounding
2
Product Code
NGT
Saline, Vascular Access Flush
2
Product Code
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
2
Product Code
NKN
Syringe, Piston, Reprocessed
2
Product Code
NRW
Stimulator, Intramuscular, Automatic
2
Product Code
NSC
Injector, Pen
2
Product Code
NTC
Nursing Pad, Hydrogel
1
Product Code
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
1
Product Code
NXH
Nursing Pad, Cohesive Gel
1
Product Code
NZG
Bassinet, Hospital
2
Product Code
NZW
Heparin, Vascular Access Flush
2
Product Code
NZX
Water, Vascular Access Flush
2
Product Code
OBK
Port, Protector/Cushion
2
Product Code
ODI
Administration Set Docking Station
2
Product Code
ODY
Tunneled Catheter Remover
2
Product Code
OJA
Intravenous Extension Tubing Set
2
Product Code
OKC
Implanted Subcutaneous Securement Catheter
2
Product Code
OKE
Port Introducer Kit
2
Product Code
OKL
Intravascular Administration Set, Automated Air Removal System
2
Product Code
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
2
Product Code
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
2
Product Code
ONM
Radiant Infant Warmer Cabinet
2
Product Code
PUK
Administration Set Securement Device
1
Product Code
OPP
Pump, Infusion, Insulin Bolus
2
Product Code
OSI
Bariatric Bed
2
Product Code
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
1
Product Code
OWL
Peripheral Catheter Insertion Kit
2
Product Code
PDH
Blanket, Neonatal Phototherapy
2
Product Code
PEF
Heparin Flush In 0.45% Sodium Chloride
2
Product Code
PEZ
Central Venous Catheter Dressing Change Kit
2
Product Code
PHC
Infusion Safety Management Software
2
Product Code
PKP
Immunoglobulin G (Igg) Infusion System
2
Product Code
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
2
Product Code
PND
Midline Catheter
2
Product Code
POQ
Blood Transfusion Kit
2
Product Code
POR
Parenteral Administration Kit
2
Product Code
PQH
Iodinated Contrast Media Transfer Tubing Set
2
Product Code
PQX
Epinephrine Syringe
2
Product Code
PRN
Pediatric Position Holder
1
Product Code
PTD
Subcutaneous Implanted Apheresis Port
2
Product Code
PTI
Non-Coring (Huber) Needle
2
Product Code
PUN
Lice Removal Kit Containing A Solution
1
Product Code
PUR
Vacuum Syringe
2
Product Code
PVZ
Non-Stainless Steel Needle
2
Product Code
PWH
Administrations Sets With Neuraxial Connectors
2
Product Code
PWN
Baby Care Kit
2
Product Code
PWO
Blood Administration Kit
2
Product Code
PWQ
Buret Administration Intravenous Kit
2
Product Code
PWR
Catheter Repair Kit
2
Product Code
PWX
Insect Sting Emergency Kit
1
Product Code
PWY
Lumbar Puncture Tray (Adult & Pediatric)
2
Product Code
PXB
Percutaneous Introducer Kit
2
Product Code
PXI
Thoracentesis Tray
2
Product Code
PXJ
Umbilical Catheter Insertion Tray
2
Product Code
PXK
Vascular Access Port Kit
2
Product Code
PXL
Venipuncture Kit
2
Product Code
PYR
Neuraxial Administration Set - Intrathecal Delivery
2
Product Code
PZW
Catheter Access Cover, Tamper-Resistant
2
Product Code
QBL
Piston Syringe Lever
2
Product Code
QDM
Midazolam Syringe
2
Product Code
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
2
Product Code
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
2
Product Code
QLF
On-Body Injector
2
Product Code
QLY
Ophthalmic Syringe
2
Product Code
QMT
Prep Kit – Vaccine Injection
2
Product Code
QNQ
Low Dead Space Piston Syringe
2
Product Code
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
2
Product Code
QOG
Injection Data Capture Device
2
Product Code
QOI
Intravenous Catheter Force-Activated Separation Device.
2
Product Code
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
2
Product Code
QYM
Ophthalmic Needle
2
Product Code
SCL
Allergen And Vaccine Delivery Needles
2
Product Code
SEF
Central Venous Catheter With Manual Insertion System
2
Product Code
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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Last synced on 20 June 2025 at 11:06 pm
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MEA
/
K002739
View Source
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002739
510(k) Type
Special
Applicant
BAXTER HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2000
Days to Decision
10 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
BRZ
Set, Blood Transfusion
BWJ
Locator, Acupuncture Point
CAK
Microfilter, Blood Transfusion
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FMF
Syringe, Piston
FMG
Stopcock, I.V. Set
FMI
Needle, Hypodermic, Single Lumen
FMS
Bed, Pediatric Open Hospital
FMT
Warmer, Infant Radiant
FMZ
Incubator, Neonatal
FNG
Lift, Patient, Ac-Powered
FNJ
Bed, Manual
FNK
Bed, Hydraulic, Adjustable Hospital
FNL
Bed, Ac-Powered Adjustable Hospital
FNM
Mattress, Air Flotation, Alternating Pressure
FNN
Nipple, Lambs Feeding
FOD
Device, Occlusion, Umbilical
FOH
Mattress, Water, Temperature Regulated
FOK
Pad, Neonatal Eye
FOS
Catheter, Umbilical Artery
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
FPA
Set, Administration, Intravascular
FPB
Filter, Infusion Line
FPK
Tubing, Fluid Delivery
FPL
Incubator, Neonatal Transport
FQH
Lavage, Jet
FQJ
Support, Scrotal, Therapeutic
FQK
Binder, Perineal
FQL
Stocking, Medical Support (For General Medical Purposes)
FQM
Bandage, Elastic
FRF
Cleaner, Air, Medical Recirculating
FRL
Fiber, Medical, Absorbent
FRN
Pump, Infusion
FRP
Holder, Infant Position
FRR
Chamber, Reverse Isolation, Patient Care
FSA
Lift, Patient, Non-Ac-Powered
FSD
Binder, Abdominal
HEF
Binder, Breast
HFS
Shield, Nipple
IKY
Mattress, Flotation Therapy, Non-Powered
KMK
Device, Intravascular Catheter Securement
KMO
Binder, Elastic
KPE
Container, I.V.
KYP
Snake Bite Suction Kit
KYQ
Kit, Chemical Snake-Bite
KZD
Infusor, Pressure, For I.V. Bags
KZE
Injector, Fluid, Non-Electrically Powered
LBI
Unit, Neonatal Phototherapy
LDR
Controller, Infusion, Intravascular, Electronic
LGM
Chamber, Patient Isolation
LGN
Chamber, Patient Transport Isolation
LGZ
Warmer, Thermal, Infusion Fluid
LHF
Warmer, Microwave, Infusion Fluid
LHI
Set, I.V. Fluid Transfer
LJL
Detectors And Removers, Lice, (Including Combs)
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
LLK
Legging, Compression, Non-Inflatable
LZH
Pump, Infusion, Enteral
MDR
Binder, Medical, Therapeutic
MEA
Pump, Infusion, Pca
K
16
2165
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
K
17
0982
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
K
14
3612
LifeCare PCA Infusion System
K
13
0394
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K
09
2313
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K
07
2144
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
K
05
1253
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K
04
3299
MEDLEY PCA MODULE, MODEL 8120
K
04
3256
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
K
04
2800
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K
03
3054
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
K
03
2233
MEDLEY PCA MODULE, MODEL 8120
K
03
1566
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K
03
0661
STRYKER PAINPUMP2
K
02
0418
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K
02
0421
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K
02
2203
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K
01
3822
MICROJET CRONO PCA
K
00
2739
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K
00
2434
PALM PUMP
K
99
0312
AVIA PAIN MEDICATION DELIVERY SYSTEM
K
98
2839
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K
94
3310
MODEL 6100 AMBULATORY INFUSION SYSTEM
K
93
4551
VERIFUSE AMBULATORY PUMP
K
92
0637
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
K
91
5270
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
K
92
1994
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K
91
5063
IVAC PC ANIFUSER
K
91
4502
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K
91
0257
BAXA PCA INFUSOR
K
91
1791
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
MEB
Pump, Infusion, Elastomeric
MEG
Syringe, Antistick
MHC
Needle, Interosseous
MHD
Pump, Infusion, Gallstone Dissolution
MJF
Check Valve, Retrograde Flow (In-Line)
MMK
Container, Sharps
MQX
Needle, Acupuncture, Single Use
MRZ
Accessories, Pump, Infusion
MZR
Topical Approximation System
NEP
System/Device, Pharmacy Compounding
NGT
Saline, Vascular Access Flush
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
NKN
Syringe, Piston, Reprocessed
NRW
Stimulator, Intramuscular, Automatic
NSC
Injector, Pen
NTC
Nursing Pad, Hydrogel
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
NXH
Nursing Pad, Cohesive Gel
NZG
Bassinet, Hospital
NZW
Heparin, Vascular Access Flush
NZX
Water, Vascular Access Flush
OBK
Port, Protector/Cushion
ODI
Administration Set Docking Station
ODY
Tunneled Catheter Remover
OJA
Intravenous Extension Tubing Set
OKC
Implanted Subcutaneous Securement Catheter
OKE
Port Introducer Kit
OKL
Intravascular Administration Set, Automated Air Removal System
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ONM
Radiant Infant Warmer Cabinet
PUK
Administration Set Securement Device
OPP
Pump, Infusion, Insulin Bolus
OSI
Bariatric Bed
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
OWL
Peripheral Catheter Insertion Kit
PDH
Blanket, Neonatal Phototherapy
PEF
Heparin Flush In 0.45% Sodium Chloride
PEZ
Central Venous Catheter Dressing Change Kit
PHC
Infusion Safety Management Software
PKP
Immunoglobulin G (Igg) Infusion System
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
PND
Midline Catheter
POQ
Blood Transfusion Kit
POR
Parenteral Administration Kit
PQH
Iodinated Contrast Media Transfer Tubing Set
PQX
Epinephrine Syringe
PRN
Pediatric Position Holder
PTD
Subcutaneous Implanted Apheresis Port
PTI
Non-Coring (Huber) Needle
PUN
Lice Removal Kit Containing A Solution
PUR
Vacuum Syringe
PVZ
Non-Stainless Steel Needle
PWH
Administrations Sets With Neuraxial Connectors
PWN
Baby Care Kit
PWO
Blood Administration Kit
PWQ
Buret Administration Intravenous Kit
PWR
Catheter Repair Kit
PWX
Insect Sting Emergency Kit
PWY
Lumbar Puncture Tray (Adult & Pediatric)
PXB
Percutaneous Introducer Kit
PXI
Thoracentesis Tray
PXJ
Umbilical Catheter Insertion Tray
PXK
Vascular Access Port Kit
PXL
Venipuncture Kit
PYR
Neuraxial Administration Set - Intrathecal Delivery
PZW
Catheter Access Cover, Tamper-Resistant
QBL
Piston Syringe Lever
QDM
Midazolam Syringe
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
QLF
On-Body Injector
QLY
Ophthalmic Syringe
QMT
Prep Kit – Vaccine Injection
QNQ
Low Dead Space Piston Syringe
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
QOG
Injection Data Capture Device
QOI
Intravenous Catheter Force-Activated Separation Device.
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
QYM
Ophthalmic Needle
SCL
Allergen And Vaccine Delivery Needles
SEF
Central Venous Catheter With Manual Insertion System
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MEA
/
K002739
View Source
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002739
510(k) Type
Special
Applicant
BAXTER HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2000
Days to Decision
10 days
Submission Type
Summary