Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution2Cleared 510(K)
- K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection Site2Cleared 510(K)
- K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)2Cleared 510(K)
- K222622Disposable Infusion Bag for Parenteral Nutrition2Cleared 510(K)
- K210749Empty EVA Bag2Cleared 510(K)
- K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL2Cleared 510(K)
- K193528Empty EVA Bag2Cleared 510(K)
- K190328HCT Empty EVA Container Pack2Cleared 510(K)
- K190305Additive Cap2Cleared 510(K)
- K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP2Cleared 510(K)
- K132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML2Cleared 510(K)
- K121161EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER2Cleared 510(K)
- K111217ADDITIVE CAP2Cleared 510(K)
- K101412EVA TPN BAG2Cleared 510(K)
- K090096ALL-IN-ONE CONTAINER2Cleared 510(K)
- K073538DUAL CHAMBER TPN CONTAINER2Cleared 510(K)
- K061197KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER2Cleared 510(K)
- K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER2Cleared 510(K)
- K041415EVA TPN CONTAINER2Cleared 510(K)
- K033916GRI-BAG, GRI-BAG AP2Cleared 510(K)
- K031419GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML2Cleared 510(K)
- K030888EVA EMPTY SOLUTION CONTAINER2Cleared 510(K)
- K020485ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML2Cleared 510(K)
- K001461TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET2Cleared 510(K)
- K001287EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML2Cleared 510(K)
- K983294ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B7122Cleared 510(K)
- K982048MPS RESERVOIR BAG2Cleared 510(K)
- K974180STERI-TAMP2Cleared 510(K)
- K973103CHARTERMED TPN-EVA BAGS2Cleared 510(K)
- K972464VITALMIX PLUS EMPTY I.V. CONTAINER2Cleared 510(K)
- K964853INTRAVIA CONTAINER, EMPTY2Cleared 510(K)
- K960581SECURE EVA DUAL CHAMBER MIXING BAG2Cleared 510(K)
- K945193ALL-IN-ONE TWO CHAMBER CONTAINER2Cleared 510(K)
- K941731EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET2Cleared 510(K)
- K932477UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET2Cleared 510(K)
- K934179DISPOSABLE BAG DECANTER2Cleared 510(K)
- K940258SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)2Cleared 510(K)
- K932649PHARMAFEED2Cleared 510(K)
- K932641EMPTY MIXING CONTAINER2Cleared 510(K)
- K932640EVA EMPTY MIXING CONTAINER2Cleared 510(K)
- K926123DUAL CHAMBER MIXING BAG2Cleared 510(K)
- K923448EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG2Cleared 510(K)
- K922214EMPTY VIAFLEX PLASTIC CONTAINER2Cleared 510(K)
- K913608SNAPPER2Cleared 510(K)
- K911567DUAL COMPARTMENT TPN BAG 3 LITER2Cleared 510(K)
- K910936EMPTY I.V. CONTAINER2Cleared 510(K)
- K911576CHEMOTHERAPY CONTAINER2Cleared 510(K)
- K910673BAG SPIGOT2Cleared 510(K)
- K902079ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION2Cleared 510(K)
- K902464CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY2Cleared 510(K)
- K895924METRICARE DRUG RESERVOIRS2Cleared 510(K)
- K883400OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE2Cleared 510(K)
- K885173MIX CONTAINER W/ATTACHED TRANSFER SET2Cleared 510(K)
- K891077MEDIVERSE PARENTERAL NUTRITION BAG2Cleared 510(K)
- K890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET2Cleared 510(K)
- K890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET2Cleared 510(K)
- K890268PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION2Cleared 510(K)
- K890272BAG DECANTER2Cleared 510(K)
- K880506MODIFIED EVA-MIX AND DI-MIX BAGS2Cleared 510(K)
- K87515560 ML RESERVOIR BAG, ITEM #2002Cleared 510(K)
- K870395CHURCHILL PARENTERAL NUTRITION BAG - EVA2Cleared 510(K)
- K871449ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG2Cleared 510(K)
- K870052INFUMIX MIXING CONTAINER2Cleared 510(K)
- K870113THERMAL JACKET FOR I.V. FLUID BAGS2Cleared 510(K)
- K870274DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER2Cleared 510(K)
- K863040DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS2Cleared 510(K)
- K860042NUTRIMIX EMPTY CONTAINER2Cleared 510(K)
- K854033SNAP-LOCK ADDITIVE CAP #SL4002Cleared 510(K)
- K854031SNAP-LOCK ADDITIVE CAP #SL1002Cleared 510(K)
- K854034SNAP-LOCK ADDITIVE CAP #SL 3002Cleared 510(K)
- K854032SNAP-LOCK ADDITIVE CAP #SL 2002Cleared 510(K)
- K852938TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK2Cleared 510(K)
- K852893VIAL DECANTER2Cleared 510(K)
- K852778BOTTLE DECANTER2Cleared 510(K)
- K852777BAG DECANTER2Cleared 510(K)
- K850035EMPTY SOLUTION TRANSFER CONTAINER2Cleared 510(K)
- K844664THE I.V. BAG2Cleared 510(K)
- K844077NUTRIMIX EMPTY CONTAINER2Cleared 510(K)
- K844410NUTRIBAG MIXING CONTAINER -2000 ML2Cleared 510(K)
- K843954MIXING CONTAINER2Cleared 510(K)
- K841597GIL-MED PARENTERAL NUTRITION OR MEDICINE2Cleared 510(K)
- K842170EMPTY SOLUTION TRANSFER CONTAINER2Cleared 510(K)
- K843523EMPTY SOLUTION TRANSFER CONTAINER 10002Cleared 510(K)
- K842628HOME NUTRIBAG MIXING CONTAINER 1000ML2Cleared 510(K)
- K842629HOME NUTRIBAG MIXING CONTAINER 3000ML2Cleared 510(K)
- K840915DIMIX CONTAINER FOR PARNETERAL NUTRIT2Cleared 510(K)
- K840388PAB IV CONTAINER2Cleared 510(K)
- K832254BAXA ADDISEAL2Cleared 510(K)
- K832247I.V. BAG ADDISEAL2Cleared 510(K)
- K830193CAT 30402Cleared 510(K)
- K830450DELMED IV CONTAINER2Cleared 510(K)
- K830299SOLUTION TRANSFER CONTAINER2Cleared 510(K)
- K830232DECANTER MODELS-VARIOUS2Cleared 510(K)
- K823538POUR BOTTLE DECANTER #20102Cleared 510(K)
- K820200IV ALERT SYSTEM2Cleared 510(K)
- K820435BAXA ADDISEAL2Cleared 510(K)
- K813435BAXA ADLI SEAL2Cleared 510(K)
- K812852SET FOR ASEPTIC DECANTING OF A FLEX I.V2Cleared 510(K)
- K812527IVA SEAL II2Cleared 510(K)
- K811268BOTTLE-TO-BOTTLE2Cleared 510(K)
- K811234I.V. BOTTLE (RIDGID)2Cleared 510(K)
- K811233I.V. PLASTIC BAG2Cleared 510(K)
- K811269GLASS VIALS2Cleared 510(K)
- K810795INSTAFIL2Cleared 510(K)
- K802966I.V. ADDITIVE CAP2Cleared 510(K)
- K801652TOTAL PARENTERAL NUTRITION SET BAG2Cleared 510(K)
- K791774LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN2Cleared 510(K)
- K791796ADDITIVE HINGE CAP2Cleared 510(K)
- K782113CAP, TAMPER PROOF PLASTIC2Cleared 510(K)
- K771432HICALIQ IVH BAG2Cleared 510(K)
- K771121EMPTY ADMIXTURE CONTAINERS2Cleared 510(K)
- K771228LIFECARE EMPTY CONTAINER2Cleared 510(K)
- K760880ADDITIVE CAP (2B8905)2Cleared 510(K)
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BAXA ADDISEAL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820435
- 510(k) Type
- Traditional
- Applicant
- BAXA CORP., SUB. OF COOK GROUP, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/8/1982
- Days to Decision
- 19 days