FDA 510(k) Applications for Medical Device Product Code "DWJ"
(System, Thermal Regulating)

FDA 510(k) Number Applicant Device Name Decision Date
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 10/10/2017
K073712 ADROIT MEDICAL SYSTEMS, INC. SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 06/06/2008
K921920 ADROIT MEDICAL SYSTEMS, INC. SOFT-TEMP 12/11/1992
K913016 ADVANCED WARMING SYSTEMS, INC. WARMTOUCH 09/04/1991
K062794 AMERICAN HEALTHCARE PRODUCTS, INC. PRN THERMALCARE, MODEL 3000 12/07/2006
K820814 AMERICAN MEDICAL SYSTEMS, INC. THERMO-K 04/29/1982
K003368 AQUARIUS MEDICAL CORP. ACROTHERM 01/19/2001
K970367 AQUARIUS MEDICAL CORP. THERMO-STAT SYSTEM 12/17/1997
K041686 ARIZANT HEALTHCARE INC. BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM 06/30/2004
K060865 ARIZANT HEALTHCARE INC. BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 04/24/2006
K053645 ARIZANT HEALTHCARE INC. MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS 03/09/2006
K092807 AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 12/10/2009
K052392 AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG PATIENT WARMING SYSTEM 05/04/2006
K094056 AUGUSTINE BIOMEDICAL & DESIGN, LLC HOTDOG MULTI FUNCTION CONTROLLER 06/03/2010
K112488 AUGUSTINE BIOMEDICAL & DESIGN, LLC HOTDOG PATIENT WARMING SYSTEM 11/23/2011
K001149 AUGUSTINE MEDICAL, INC. AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK 09/06/2000
K920432 AUGUSTINE MEDICAL, INC. BAIR HUGGER CUB BLANKET- SHORT MODEL 536 06/18/1992
K950416 AUGUSTINE MEDICAL, INC. BAIR HUGGER MODEL 600 UNIT, BLANKETS 08/29/1995
K964673 AUGUSTINE MEDICAL, INC. BAIR HUGGER MODEL 630 CARDIAC BLANKET 06/26/1997
K952864 AUGUSTINE MEDICAL, INC. BAIR HUGGER MODEL 655 BLANKET 09/12/1995
K920265 AUGUSTINE MEDICAL, INC. BAIR HUGGER PATIENT WARMING SYSTEM 03/27/1992
K021473 AUGUSTINE MEDICAL, INC. BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM 07/09/2002
K921165 AUGUSTINE MEDICAL, INC. BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 08/06/1992
K913734 AUGUSTINE MEDICAL, INC. BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER 10/23/1991
K903360 AUGUSTINE MEDICAL, INC. BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION 08/14/1990
K873745 AUGUSTINE MEDICAL, INC. BAIR HUGGER(TM) - PATIENT WARMING SYSTEM 11/06/1987
K960167 AUGUSTINE MEDICAL, INC. SYSTEM, THERMAL REGULATING 74-DWJ 06/17/1996
K014210 AVACORE TECHNOLOGIES, INC. PALMO THERMOREGULATION INTERFACE ACCESSORY 08/16/2002
K023934 AVACORE TECHNOLOGIES, INC. RAPID THERMAL EXCHANGE SYSTEM 01/23/2003
K882442 BAXTER HEALTHCARE CORP. RK2000 K-THERMIA SYSTEM 09/06/1988
K162562 BCG MEDICAL, LLC OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY 03/17/2017
K894980 BIO MEDICUS, INC. BIO-CAL 370 HEATER/COOLER 11/02/1989
K180375 Brain Cool AB The IQoolTM Warm System 05/18/2018
K882035 BUCKMAN CO., INC. HEART-CHILL SALINE SLUSH PAD 07/28/1988
K812955 CAIRCO LTD. EAST WATER UNIT MARK 3 12/29/1981
K140635 CARE ESSENTIALS PTY LTD COCOON CONVECTIVE WARMING SYSTEM 07/25/2014
K772015 CAROLINA MEDICAL ELECTRONICS PATIENT HEATER SYSTEM, MODEL PH112 11/15/1977
K811742 CINCINNATI SUB-ZERO HEMOTHERM MODEL 400 08/13/1981
K811743 CINCINNATI SUB-ZERO MAXITHERM 07/16/1981
K101148 CINCINNATI SUB-ZERO PRODUCTS, INC WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS 10/01/2010
K123946 CINCINNATI SUB-ZERO PRODUCTS, INC WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS 01/17/2013
K110104 CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM 02/04/2011
K101589 CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS 09/20/2010
K120081 CINCINNATI SUB-ZERO PRODUCTS, INC. NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS 02/17/2012
K942790 CINCINNATI SUB-ZERO PRODUCTS, INC. WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) 01/24/1995
K942599 CINCINNATI SUB-ZERO PRODUCTS, INC. WARM AIR WARMING UNIT 01/24/1995
K121669 CINCINNATI SUB-ZERO PRODUCTS, INC. WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) 07/03/2012
K910327 CINCINNATI SUB-ZERO PRODUCTS, INC. WARMAIR SYSTEM 05/16/1991
K123083 COVIDIEN COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT 04/17/2013
K131361 COVIDIEN WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET 07/29/2013
K040911 DYNATHERM MEDICAL, INC. VITALHEAT 06/22/2004
K963731 ENTHERMICS MEDICAL SYSTEMS, INC. TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT 04/22/1997
K102856 GALMAZ BIOTECH S.L. SIROCCO THERMAL REGULATING SYSTEM 06/30/2011
K800812 GAYMAR INDUSTRIES, INC. MEDI-THERM 04/24/1980
K912051 GAYMAR INDUSTRIES, INC. MEDI-THERM (MTA-5900) & DETACHABLE HOSES 07/30/1991
K100585 GAYMAR INDUSTRIES, INC. MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 01/20/2011
K942881 GAYMAR INDUSTRIES, INC. TC 3000 05/23/1995
K914805 GAYMAR INDUSTRIES, INC. TC-1000, TC-1050 SYSTEM 01/07/1992
K930345 GAYMAR INDUSTRIES, INC. TC2000 POWER UNIT AND ACCESSORIES 08/06/1993
K093694 GERATHERM MEDICAL AG GERATHERM UNIQUERESC 09/20/2010
K093244 GERATHERM MEDICAL AG UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX 10/19/2010
K960511 GIBECK, INC. GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET 01/13/1997
K964377 GIBECK, INC. THERMAL REGULATION SYSTEM BLANKET 04/23/1997
K770839 GORMAN RUPP INDUSTRIES AQUAMATIC K-77 06/08/1977
K771537 GORMAN RUPP INDUSTRIES AQUAMATIC K-MODULE MODEL K-20 09/06/1977
K761087 GORMAN RUPP INDUSTRIES ELECTRONIC CONTROL UNIT 12/06/1976
K072513 GVP ELETTRONICA SRL DM-EMG 12/07/2007
K973705 HILL-ROM, INC. CONTOR TABLE SURFACE 08/07/1998
K040440 HTTP HYPOTHERMIA THERAPY HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) 04/27/2004
K061902 INDITHERM MEDICAL COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 12/08/2006
K051419 INDITHERM MEDICAL INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 04/27/2006
K140078 INSPIRATION HEALTHCARE LTD TECOTHERM NEO (T NEO) 11/14/2014
K162679 IOB MEDICAL INC IOB Temperature Management System 04/28/2017
K033021 KIMBERLY-CLARK CORP. KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS 11/12/2003
K031728 KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET 10/12/2004
K011859 KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS 05/01/2002
K943276 MALLINCKRODT MEDICAL WARMTOUCH PLASTIC WARMING COVER 09/19/1994
K904690 MARQUEST MEDICAL PRODUCTS, INC. TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM 02/01/1991
K902650 MEDADVANCES, INC. BODYHEAT 12/20/1990
K070112 MEDCOOL INC RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM 07/13/2007
K890575 MEDICAL REPACKERS CO. ACCUTHERM PTS-200 05/05/1989
K161602 Medivance, Inc. Arctic Sun Temperature Management System 09/02/2016
K142702 MEDIVANCE, INC. Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad 12/18/2014
K002577 MEDIVANCE, INC. ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS 10/26/2000
K101092 MEDIVANCE, INC. ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 07/16/2010
K010338 MEDIVANCE, INC. ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 03/07/2001
K120849 MEDIVANCE, INC. HYBRID ARCTICGEL PAD 07/20/2012
K071341 MEDIVANCE, INC. MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 08/03/2007
K022903 MICROTEK MEDICAL, INC. CHILLBUSTER 11/27/2002
K132048 MOLNLYCKE HEALTH CARE US, LLC BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET 11/06/2013
K992386 MTRE ADVANCED TECHNOLOGY LTD. ALLON 2000 03/07/2000
K001546 MTRE ADVANCED TECHNOLOGY LTD. ALLON 2001 06/08/2000
K003349 MTRE ADVANCED TECHNOLOGY LTD. ALLON 2001 MODIFIED 11/13/2000
K024128 MTRE ADVANCED TECHNOLOGY LTD. ALLON 2001 VERSION 5 02/10/2003
K083662 MTRE ADVANCED TECHNOLOGY LTD. CRITICOOL 03/26/2009
K102112 MTRE ADVANCED TECHNOLOGY LTD. CRITICOOL PRO 11/18/2010
K014121 NELLCOR PURITAN BENNETT, INC. WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 01/11/2002
K020604 NELLCOR PURITAN BENNETT, INC. WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 04/23/2002
K801253 PENLON, INC. CREST ELECTRONIC WARMING BLANKET 01/02/1981
K113705 PINTLER MEDICAL PINTLER PATIENT WARMING SYSTEM 08/31/2012
K952329 PROGRESSIVE DYNAMICS, INC. LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM 01/17/1996
K914382 PROGRESSIVE DYNAMICS, INC. LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM 04/21/1992
K933764 PROGRESSIVE DYNAMICS, INC. LIFE-AIR 1000 PATIENT WARMING COVER 11/09/1993
K914383 PROGRESSIVE DYNAMICS, INC. LIFE-AIR 1000 PATIENT WARMING COVERS 03/30/1992
K051336 R.G. ENTERPRISES, INC. GERATHERM SOS-RESCUE BAG 06/29/2006
K873546 REIMERS ENGINEERING, INC. VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM 01/29/1988
K051097 RG ENT., INC. GERATHERM SOS-RESCUE BLANKET 02/24/2006
K051278 RG ENT., INC. GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) 06/29/2006
K881322 SEABROOK MEDICAL SYSTEMS, INC. MINI-TEMP(TM) 06/22/1988
K902756 SEABROOK MEDICAL SYSTEMS, INC. TROPI-COOL 10/22/1990
K923104 SEABROOK MEDICAL SYSTEMS, INC. TROPIC-AIR 07/13/1993
K946196 SEABROOK MEDICAL SYSTEMS, INC. TROPICAIR CONVECTIVE WARING SYSTEM 09/06/1995
K952086 SEABROOK MEDICAL SYSTEMS, INC. TROPICAIR CONVECTIVE WARMING BLANKETS 09/06/1995
K900186 SHILEY, INC. BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET 04/10/1990
K011907 SIMS LEVEL 1, INC. SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM 12/18/2001
K141686 SMITH MEDICAL ASD, INC. EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY 10/28/2014
K181699 Smiths Medical ASD, Inc. Level 1 Convective Warmer 07/26/2018
K083336 SMITHS MEDICAL ASD, INC. LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 06/03/2009
K061513 SMITHS MEDICAL ASD, INC. LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET 08/01/2006
K040632 SMITHS MEDICAL ASD, INC. SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 04/27/2004
K152266 STRYKER MEDICAL Altrix Precision Temperature Management System 12/02/2016
K180834 Stryker Medical Altrix Precision Temperature Management System 08/10/2018
K171149 Stryker Medical Altrix Temperature Management Wraps 07/18/2017
K080763 TALLEY MEDICAL TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT 05/30/2008
K101705 THE SURGICAL COMPANY INTERNATIONAL BV MISTRAL-AIR WARMING SYSTEM 07/02/2010
K171234 The Surgical Company International BV (as The 37Company) Mistral-Air Warming Unit 05/26/2017
K991684 THERMOGEAR, INC. CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 03/01/2000
K071918 THERMOGEAR, INC. CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 11/09/2007
K083135 THERMOGEAR, INC. MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 10/31/2008
K854856 THERMORITE, INC. THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT 06/02/1986
K132454 VITAHEAT MEDICAL, LLC VITAHEAT PATIENT WARMING SYSTEM 10/04/2013
K121720 WELKINS, LLC WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM 08/20/2012
K981093 WESCO, INC. WESCO BLANKET 03/28/2000


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