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 |
K201779 |
Augustine Temperature Management |
HotDog Temperature Management Controller |
09/11/2020 |
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 |
K190221 |
IOB Medical Inc |
IOB Warming Blankets |
10/25/2019 |
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 |
K200225 |
Medivance, Inc. |
Arctic Sun Stat Temperature Management System |
02/28/2020 |
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 |
K200446 |
STERIS Corporation |
STERIS Patient Warming System |
06/13/2020 |
K202197 |
Stihler Electronic GmbH |
Astopad Patient Warming System |
09/04/2020 |
K180834 |
Stryker Medical |
Altrix Precision Temperature Management System |
08/10/2018 |
K152266 |
STRYKER MEDICAL |
Altrix Precision Temperature Management System |
12/02/2016 |
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 |