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 |
| K181671 | Care Essentials Pty Ltd | Cocoon Convective Warming System | 05/02/2019 |
| 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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