Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- K251974Arctic Sun Temperature Management System (Model 5000)2Cleared 510(K)
- K242964Celsi Warmer2Cleared 510(K)
- K243942Arctic Sun Stat Temperature Management System2Cleared 510(K)
- K232627HotDog Warming Mattress + Return Electrode2Cleared 510(K)
- K232502Cocoon Convective Warming System, Model CWS70002Cleared 510(K)
- K231211Medline ComfortTemp Patient Warming System2Cleared 510(K)
- K232638FilteredFlo Warming Blankets2Cleared 510(K)
- K232844The IQoolTM System2Cleared 510(K)
- K232508Barrier EasyWarm Active Self-Warming Blanket2Cleared 510(K)
- K231596IOB Temperature Management System2Cleared 510(K)
- K230866HotDog Warming Mattress + Return Electrode2Cleared 510(K)
- K221669IOB Warming Blankets2Cleared 510(K)
- K220941HotDog Temperature Management System2Cleared 510(K)
- K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation2Cleared 510(K)
- K2106033M Bair Hugger Temperature Management System (Model 675)2Cleared 510(K)
- K203085NOVA Patient Warming System2Cleared 510(K)
- K201779HotDog Temperature Management Controller2Cleared 510(K)
- K202197Astopad Patient Warming System2Cleared 510(K)
- K200446STERIS Patient Warming System2Cleared 510(K)
- K200225Arctic Sun Stat Temperature Management System2Cleared 510(K)
- K190221IOB Warming Blankets2Cleared 510(K)
- K181671Cocoon Convective Warming System2Cleared 510(K)
- K180834Altrix Precision Temperature Management System2Cleared 510(K)
- K181699Level 1 Convective Warmer2Cleared 510(K)
- K180375The IQoolTM Warm System2Cleared 510(K)
- K1713733M Bair Hugger Model 675 Total Temperature Management System2Cleared 510(K)
- K171149Altrix Temperature Management Wraps2Cleared 510(K)
- K171234Mistral-Air Warming Unit2Cleared 510(K)
- K162679IOB Temperature Management System2Cleared 510(K)
- K162562OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY2Cleared 510(K)
- K152266Altrix Precision Temperature Management System2Cleared 510(K)
- K161602Arctic Sun Temperature Management System2Cleared 510(K)
- K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad2Cleared 510(K)
- K140078TECOTHERM NEO (T NEO)2Cleared 510(K)
- K141686EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY2Cleared 510(K)
- K140635COCOON CONVECTIVE WARMING SYSTEM2Cleared 510(K)
- K132048BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET2Cleared 510(K)
- K132454VITAHEAT PATIENT WARMING SYSTEM2Cleared 510(K)
- K131361WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET2Cleared 510(K)
- K123083COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT2Cleared 510(K)
- K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS2Cleared 510(K)
- K113705PINTLER PATIENT WARMING SYSTEM2Cleared 510(K)
- K121720WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM2Cleared 510(K)
- K120849HYBRID ARCTICGEL PAD2Cleared 510(K)
- K121669WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)2Cleared 510(K)
- K120081NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS2Cleared 510(K)
- K112488HOTDOG PATIENT WARMING SYSTEM2Cleared 510(K)
- K102856SIROCCO THERMAL REGULATING SYSTEM2Cleared 510(K)
- K110104BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM2Cleared 510(K)
- K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA79002Cleared 510(K)
- K102112CRITICOOL PRO2Cleared 510(K)
- K093244UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX2Cleared 510(K)
- K101148WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS2Cleared 510(K)
- K101589BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS2Cleared 510(K)
- K093694GERATHERM UNIQUERESC2Cleared 510(K)
- K101092ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 50002Cleared 510(K)
- K101705MISTRAL-AIR WARMING SYSTEM2Cleared 510(K)
- K094056HOTDOG MULTI FUNCTION CONTROLLER2Cleared 510(K)
- K092807HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M1032Cleared 510(K)
- K083336LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL2Cleared 510(K)
- K083662CRITICOOL2Cleared 510(K)
- K083135MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 80022Cleared 510(K)
- K073712SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA01002Cleared 510(K)
- K080763TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT2Cleared 510(K)
- K072513DM-EMG2Cleared 510(K)
- K071918CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 80022Cleared 510(K)
- K071341MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 20002Cleared 510(K)
- K070112RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM2Cleared 510(K)
- K061902COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU12Cleared 510(K)
- K062794PRN THERMALCARE, MODEL 30002Cleared 510(K)
- K061513LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET2Cleared 510(K)
- K051336GERATHERM SOS-RESCUE BAG2Cleared 510(K)
- K051278GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)2Cleared 510(K)
- K052392HOT DOG PATIENT WARMING SYSTEM2Cleared 510(K)
- K051419INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB12Cleared 510(K)
- K060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 8502Cleared 510(K)
- K053645MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS2Cleared 510(K)
- K051097GERATHERM SOS-RESCUE BLANKET2Cleared 510(K)
- K031728KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET2Cleared 510(K)
- K041686BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM2Cleared 510(K)
- K040911VITALHEAT2Cleared 510(K)
- K040632SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW40002Cleared 510(K)
- K040440HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)2Cleared 510(K)
- K033021KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS2Cleared 510(K)
- K024128ALLON 2001 VERSION 52Cleared 510(K)
- K023934RAPID THERMAL EXCHANGE SYSTEM2Cleared 510(K)
- K022903CHILLBUSTER2Cleared 510(K)
- K014210PALMO THERMOREGULATION INTERFACE ACCESSORY2Cleared 510(K)
- K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM2Cleared 510(K)
- K011859KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS2Cleared 510(K)
- K020604WARMTOUCH PATIENT WARMING SYSTEM, MODEL 53002Cleared 510(K)
- K014121WARMTOUCH CARDIAC BLANKET,CATALOG # 503-08602Cleared 510(K)
- K011907SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM2Cleared 510(K)
- K010338ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2002Cleared 510(K)
- K003368ACROTHERM2Cleared 510(K)
- K003349ALLON 2001 MODIFIED2Cleared 510(K)
- K002577ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS2Cleared 510(K)
- K001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK2Cleared 510(K)
- K001546ALLON 20012Cleared 510(K)
- K981093WESCO BLANKET2Cleared 510(K)
- K992386ALLON 20002Cleared 510(K)
- K991684CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 80012Cleared 510(K)
- K973705CONTOR TABLE SURFACE2Cleared 510(K)
- K970367THERMO-STAT SYSTEM2Cleared 510(K)
- K964673BAIR HUGGER MODEL 630 CARDIAC BLANKET2Cleared 510(K)
- K964377THERMAL REGULATION SYSTEM BLANKET2Cleared 510(K)
- K963731TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT2Cleared 510(K)
- K960511GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET2Cleared 510(K)
- K960167SYSTEM, THERMAL REGULATING 74-DWJ2Cleared 510(K)
- K952329LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM2Cleared 510(K)
- K952864BAIR HUGGER MODEL 655 BLANKET2Cleared 510(K)
- K952086TROPICAIR CONVECTIVE WARMING BLANKETS2Cleared 510(K)
- K946196TROPICAIR CONVECTIVE WARING SYSTEM2Cleared 510(K)
- K950416BAIR HUGGER MODEL 600 UNIT, BLANKETS2Cleared 510(K)
- K942881TC 30002Cleared 510(K)
- K942790WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)2Cleared 510(K)
- K942599WARM AIR WARMING UNIT2Cleared 510(K)
- K943276WARMTOUCH PLASTIC WARMING COVER2Cleared 510(K)
- K940171CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM2Cleared 510(K)
- K933764LIFE-AIR 1000 PATIENT WARMING COVER2Cleared 510(K)
- K930345TC2000 POWER UNIT AND ACCESSORIES2Cleared 510(K)
- K923104TROPIC-AIR2Cleared 510(K)
- K921920SOFT-TEMP2Cleared 510(K)
- K921165BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 5402Cleared 510(K)
- K920432BAIR HUGGER CUB BLANKET- SHORT MODEL 5362Cleared 510(K)
- K914382LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM2Cleared 510(K)
- K914383LIFE-AIR 1000 PATIENT WARMING COVERS2Cleared 510(K)
- K920265BAIR HUGGER PATIENT WARMING SYSTEM2Cleared 510(K)
- K914805TC-1000, TC-1050 SYSTEM2Cleared 510(K)
- K913734BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER2Cleared 510(K)
- K913016WARMTOUCH2Cleared 510(K)
- K912051MEDI-THERM (MTA-5900) & DETACHABLE HOSES2Cleared 510(K)
- K910327WARMAIR SYSTEM2Cleared 510(K)
- K904690TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM2Cleared 510(K)
- K902650BODYHEAT2Cleared 510(K)
- K902756TROPI-COOL2Cleared 510(K)
- K903360BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION2Cleared 510(K)
- K900186BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET2Cleared 510(K)
- K894980BIO-CAL 370 HEATER/COOLER2Cleared 510(K)
- K890575ACCUTHERM PTS-2002Cleared 510(K)
- K882442RK2000 K-THERMIA SYSTEM2Cleared 510(K)
- K882035HEART-CHILL SALINE SLUSH PAD2Cleared 510(K)
- K881322MINI-TEMP(TM)2Cleared 510(K)
- K873546VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM2Cleared 510(K)
- K873745BAIR HUGGER(TM) - PATIENT WARMING SYSTEM2Cleared 510(K)
- K854856THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT2Cleared 510(K)
- K820814THERMO-K2Cleared 510(K)
- K812955EAST WATER UNIT MARK 32Cleared 510(K)
- K811742HEMOTHERM MODEL 4002Cleared 510(K)
- K811743MAXITHERM2Cleared 510(K)
- K801253CREST ELECTRONIC WARMING BLANKET2Cleared 510(K)
- K800812MEDI-THERM2Cleared 510(K)
- K772015PATIENT HEATER SYSTEM, MODEL PH1122Cleared 510(K)
- K771537AQUAMATIC K-MODULE MODEL K-202Cleared 510(K)
- K770839AQUAMATIC K-772Cleared 510(K)
- K761087ELECTRONIC CONTROL UNIT2Cleared 510(K)
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
- Page Type
- Cleared 510(K)
- 510(k) Number
- K162562
- 510(k) Type
- Traditional
- Applicant
- Bcg Medical, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/17/2017
- Days to Decision
- 184 days
- Submission Type
- Summary