Anesthesiology
Review Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- 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
- 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
- K240624InfuLife2Cleared 510(K)
- K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)2Cleared 510(K)
- K181360ON-Q* Pump with Bolus2Cleared 510(K)
- K151650SMARTez elastomeric infusion pump2Cleared 510(K)
- K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES2Cleared 510(K)
- K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM2Cleared 510(K)
- K090300MODIFICATION TO AUTOFUSER2Cleared 510(K)
- K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP2Cleared 510(K)
- K071532ALPHA INFUSION PUMP, MODEL A200, A4502Cleared 510(K)
- K072921DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM2Cleared 510(K)
- K072053SMARTBLOCK PAIN PUMP2Cleared 510(K)
- K071735MODIFICATION TO DISPOSABLE INFUSION PUMP KIT2Cleared 510(K)
- K071222INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES2Cleared 510(K)
- K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP2Cleared 510(K)
- K061661STA CATH ATTACHABLE INFISION CATHETER, MODEL STA202Cleared 510(K)
- K062457INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES2Cleared 510(K)
- K061409SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET2Cleared 510(K)
- K060258AUTOFUSER2Cleared 510(K)
- K060933SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM2Cleared 510(K)
- K052999SEMPERFLO INFUSION SYSTEM2Cleared 510(K)
- K051828NIPRO SUREFUSER AMBULATORY INFUSION PUMP2Cleared 510(K)
- K052451MPS ACACIA MEDFLO ELASTOMERIC PUMP2Cleared 510(K)
- K052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)2Cleared 510(K)
- K051474SYMBIOS DISPOSABLE INFUSION PUMP KIT2Cleared 510(K)
- K050770MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT2Cleared 510(K)
- K042122SMARTINFUSER PAINPUMP2Cleared 510(K)
- K042246MULTI-DRIP INFUSION CATHETER2Cleared 510(K)
- K041585AUTOFUSER AMBULATORY INFUSION PUMP2Cleared 510(K)
- K040337I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)2Cleared 510(K)
- K040752DOSI-FUSER2Cleared 510(K)
- K033039MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS2Cleared 510(K)
- K030830B. BRAUN NERVE BLOCK CATHETER2Cleared 510(K)
- K023883HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO2Cleared 510(K)
- K023098ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT2Cleared 510(K)
- K023318I-FLOW ELASTOMERIC PUMP WITH BOLUS2Cleared 510(K)
- K021964ALPHA INFUSION PUMP AND CATHETERS2Cleared 510(K)
- K021274PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C17192Cleared 510(K)
- K020988PAIN CARE 42002Cleared 510(K)
- K020862I-FLOW ELASTOMERIC PUMP2Cleared 510(K)
- K020660HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO2Cleared 510(K)
- K013928PAIN CARE 32002Cleared 510(K)
- K011117MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS2Cleared 510(K)
- K011317MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM2Cleared 510(K)
- K010824PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT2Cleared 510(K)
- K003915ACCUFUSER; ACCUFUSER PLUS2Cleared 510(K)
- K003476MPS ACACIA PAIN KIT2Cleared 510(K)
- K002073PAIN CARE 30002Cleared 510(K)
- K001342P.O.P. PAIN KIT2Cleared 510(K)
- K002321PAIN CARE 2000L2Cleared 510(K)
- K000263GO MEDICAL BALLOON INFUSION SYSTEM2Cleared 510(K)
- K993832AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 102Cleared 510(K)
- K993972DISPOSABLE INFUSION PUMP KIT2Cleared 510(K)
- K992551ALPHA INFUSION PUMP2Cleared 510(K)
- K991543INTRAOP CATHETER2Cleared 510(K)
- K992015FREEDOM INFUSION SYSTEM2Cleared 510(K)
- K990461MCKINLEY SP DISPOSABLE INFUSION PUMP2Cleared 510(K)
- K990889AUTODOSE INFUSION SYSTEM2Cleared 510(K)
- K984502NERVE BLOCK INFUSION KIT2Cleared 510(K)
- K983634PREPARE HOME INFUSION PUMP2Cleared 510(K)
- K983454PAIN CARE 20002Cleared 510(K)
- K982946PAINBUSTER INFUSION KIT2Cleared 510(K)
- K982256OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP2Cleared 510(K)
- K982102SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY2Cleared 510(K)
- K980558PAINBUSTER INFUSION SYSTEM2Cleared 510(K)
- K972158GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES2Cleared 510(K)
- K971362PERSONAL INFUSOR2Cleared 510(K)
- K972173MEDI-SIS SYRINGE INFUSION SYSTEM2Cleared 510(K)
- K971168ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE2Cleared 510(K)
- K965222MICROJECT MODEL PCA-12Cleared 510(K)
- K963355SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET2Cleared 510(K)
- K962663SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET2Cleared 510(K)
- K960318DIB INFUSOR-RA2Cleared 510(K)
- K955849DIB INFUSOR2Cleared 510(K)
- K955727BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET2Cleared 510(K)
- K954059TITAN 20 CC DRIVER2Cleared 510(K)
- K953028TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET2Cleared 510(K)
- K941418INFUSION PUMP2Cleared 510(K)
- K944665DIB INFUSORS2Cleared 510(K)
- K943664INTERMATE XLV ELASTOMERIC INFUSION SYSTEM2Cleared 510(K)
- K940406DISPOSABLE, AMBULATORY, INFUSION PUMPS2Cleared 510(K)
- K941766DIB INFUSOR2Cleared 510(K)
- K940117MID-5002Cleared 510(K)
- K930404DIB INFUSOR2Cleared 510(K)
- K922382INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE2Cleared 510(K)
- K914148PRIME CADI-1202Cleared 510(K)
- K911636GENESIS(TM) INFUSION SYSTEM2Cleared 510(K)
- K913658IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD2Cleared 510(K)
- 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
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K993832
- 510(k) Type
- Traditional
- Applicant
- TANDEM MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/9/2000
- Days to Decision
- 89 days
- Submission Type
- Summary