Anesthesiology
Review Panel
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- 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
- 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
- K251733Fluido® AirGuard System2Cleared 510(K)
- K232107°M Warmer System2Cleared 510(K)
- K211618Fluido Compact Blood and Fluid Warming System2Cleared 510(K)
- K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer2Cleared 510(K)
- K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System2Cleared 510(K)
- K213191S-Line2Cleared 510(K)
- K192325Quantum Blood and Fluid Warming System2Cleared 510(K)
- K180842MAC Medical D-Series Blanket and Solution Warming Cabinets2Cleared 510(K)
- K181775Quantum Blood and IV Fluid Infusion Warmer2Cleared 510(K)
- K180154QiF Blood and Fluid Warmer2Cleared 510(K)
- K171215QiF Blood and Fluid Warmer2Cleared 510(K)
- K163708QiF Blood and Fluid Warmer2Cleared 510(K)
- K161613Hang&Go PAC2Cleared 510(K)
- K150404QiF Blood and Fluid Warmer2Cleared 510(K)
- K152208The Belmont Hyperthermia Pump2Cleared 510(K)
- K150484Penguin In-Line Warmer2Cleared 510(K)
- K132202DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET2Cleared 510(K)
- K131519BELMONT HYPERTHERMIA PUMP2Cleared 510(K)
- K132110NATUS WARMETTE BLANKET AND DUAL CABINETS2Cleared 510(K)
- K130867ENFLOW IV FLUID WARMER INSULATED STRAP2Cleared 510(K)
- K122449ENTERAL NUTRITION WARMER2Cleared 510(K)
- K121775ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER2Cleared 510(K)
- K121198BW685, BW685S2Cleared 510(K)
- K120860INFU BOX TYPE 0412A2Cleared 510(K)
- K120026PERFORMER HT/ HANG&GO HT BASIC2Cleared 510(K)
- K112702IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS2Cleared 510(K)
- K102900HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM2Cleared 510(K)
- K112902ENFLOW IV FLUID WARMER2Cleared 510(K)
- K111870AMSCO WARMING CABINET2Cleared 510(K)
- K110769AMSCO WARMING CABINET2Cleared 510(K)
- K103801HYPOTHERMX INTRAVENOUS FLUID WARMER2Cleared 510(K)
- K091336IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V2Cleared 510(K)
- K092366TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE2Cleared 510(K)
- K092823AMSCO WARMING CABINET2Cleared 510(K)
- K090089BELMONT HYPERTHERMIA PUMP2Cleared 510(K)
- K082765ASTOFLO PLUS2Cleared 510(K)
- K082217RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM2Cleared 510(K)
- K072080NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,2Cleared 510(K)
- K073363THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 3002Cleared 510(K)
- K062644FLEXWARMER, MODELS KZ-1 AND KZ-22Cleared 510(K)
- K070654HYPERTHERMIA PUMP2Cleared 510(K)
- K060851SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER2Cleared 510(K)
- K052055SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-12002Cleared 510(K)
- K060939RANGER IRRIGATION FLUID WARMING SYSTEM2Cleared 510(K)
- K060537EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 1202Cleared 510(K)
- K0418398NONE2Cleared 510(K)
- K032778LARGE VOLUME FLUID RESERVOIR2Cleared 510(K)
- K032674BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS20002Cleared 510(K)
- K031390MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-7122Cleared 510(K)
- K024373MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-52Cleared 510(K)
- K023653MAXONE IV FLUID/BLOOD WARMER, MODEL 1022Cleared 510(K)
- K012832COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-2002Cleared 510(K)
- K012906ANIMEC, MODELS AM-2S-4 AND AM-2S-52Cleared 510(K)
- K012276TEMP 32Cleared 510(K)
- K002409MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER2Cleared 510(K)
- K001764HOTLINE 2 FLUID WARMER2Cleared 510(K)
- K981509TEMPO III2Cleared 510(K)
- K980086HEAT STACK2Cleared 510(K)
- K973748TEMPO AND TEMP H202Cleared 510(K)
- K954769BIEGLER BW385L BLOOD & INFUSION WARMER2Cleared 510(K)
- K955659DRUGBOX2Cleared 510(K)
- K922786THERM O DRUG MODEL HT-7472Cleared 510(K)
- K914867QWIK-1(TM) IN-LINE IV FLUID WARMER2Cleared 510(K)
- K914364ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.2Cleared 510(K)
- K921395HOT SACK2Cleared 510(K)
- K911383HOTLINE FLUID WARMER2Cleared 510(K)
- K904252HEATWAVE2Cleared 510(K)
- K896018BIOTEMP2Cleared 510(K)
- K883873INFUSION FLUID WARMER2Cleared 510(K)
- K882361STIHLER ASTOTHERM IFT 200, IFT 2202Cleared 510(K)
- K822098BT 794-BLOOD/FLUID WARMER2Cleared 510(K)
- K813161FLO TEM II (BLOOD/FLUID WARMER2Cleared 510(K)
- K803249FLUID WARMER2Cleared 510(K)
- 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
Penguin In-Line Warmer
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150484
- 510(k) Type
- Traditional
- Applicant
- Creche Innovations
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/9/2015
- Days to Decision
- 135 days
- Submission Type
- Summary