FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K171373 |
3M Company |
3M Bair Hugger Model 675 Total Temperature Management System |
10/10/2017 |
K210603 |
3M Company |
3M Bair Hugger Temperature Management System (Model 675) |
03/30/2021 |
K210605 |
3M Company |
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation |
04/29/2021 |
K073712 |
ADROIT MEDICAL SYSTEMS, INC. |
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 |
06/06/2008 |
K062794 |
AMERICAN HEALTHCARE PRODUCTS, INC. |
PRN THERMALCARE, MODEL 3000 |
12/07/2006 |
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 |
K964673 |
AUGUSTINE MEDICAL, INC. |
BAIR HUGGER MODEL 630 CARDIAC BLANKET |
06/26/1997 |
K021473 |
AUGUSTINE MEDICAL, INC. |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
07/09/2002 |
K960167 |
AUGUSTINE MEDICAL, INC. |
SYSTEM, THERMAL REGULATING 74-DWJ |
06/17/1996 |
K201779 |
Augustine Temperature Management |
HotDog Temperature Management Controller |
09/11/2020 |
K220941 |
Augustine Temperature Management |
HotDog Temperature Management System |
09/23/2022 |
K230866 |
Augustine Temperature Management, LLC |
HotDog Warming Mattress + Return Electrode |
06/29/2023 |
K014210 |
AVACORE TECHNOLOGIES, INC. |
PALMO THERMOREGULATION INTERFACE ACCESSORY |
08/16/2002 |
K023934 |
AVACORE TECHNOLOGIES, INC. |
RAPID THERMAL EXCHANGE SYSTEM |
01/23/2003 |
K162562 |
BCG MEDICAL, LLC |
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY |
03/17/2017 |
K180375 |
Brain Cool AB |
The IQoolTM Warm System |
05/18/2018 |
K232844 |
BrainCool AB |
The IQoolTM System |
10/04/2023 |
K181671 |
Care Essentials Pty Ltd |
Cocoon Convective Warming System |
05/02/2019 |
K140635 |
CARE ESSENTIALS PTY LTD |
COCOON CONVECTIVE WARMING SYSTEM |
07/25/2014 |
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 |
K121669 |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) |
07/03/2012 |
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 |
K203085 |
Encompass Group, LLC |
NOVA Patient Warming System |
11/12/2020 |
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 |
K100585 |
GAYMAR INDUSTRIES, INC. |
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 |
01/20/2011 |
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 |
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 |
K231596 |
IOB Medical Inc |
IOB Temperature Management System |
06/30/2023 |
K190221 |
IOB Medical Inc |
IOB Warming Blankets |
10/25/2019 |
K221669 |
IOB Medical Inc |
IOB Warming Blankets |
12/27/2022 |
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 |
K070112 |
MEDCOOL INC |
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM |
07/13/2007 |
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 |
K232508 |
Molnlycke Health Care US, LLC |
Barrier EasyWarm Active Self-Warming Blanket |
09/15/2023 |
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 |
K113705 |
PINTLER MEDICAL |
PINTLER PATIENT WARMING SYSTEM |
08/31/2012 |
K952329 |
PROGRESSIVE DYNAMICS, INC. |
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM |
01/17/1996 |
K051336 |
R.G. ENTERPRISES, INC. |
GERATHERM SOS-RESCUE BAG |
06/29/2006 |
K051097 |
RG ENT., INC. |
GERATHERM SOS-RESCUE BLANKET |
02/24/2006 |
K051278 |
RG ENT., INC. |
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) |
06/29/2006 |
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 |
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 |
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 |