FDA Product Code
FDA Product Code DWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5900
510(k) Clearances — 161 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-08-21 | Traditional | PDF ↗ |
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 | Special | PDF ↗ |
| K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | 2026-07-08 | Traditional | PDF ↗ |
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 | Traditional | PDF ↗ |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025-10-24 | Traditional | PDF ↗ |
| K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025-06-20 | Traditional | PDF ↗ |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025-04-30 | Traditional | PDF ↗ |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2024-04-18 | Special | PDF ↗ |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024-02-21 | Traditional | PDF ↗ |
| K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | 2023-12-01 | Traditional | PDF ↗ |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023-10-24 | Traditional | PDF ↗ |
| K232844 | The IQoolTM System | Braincool AB | 2023-10-04 | Special | PDF ↗ |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | 2023-09-15 | Special | PDF ↗ |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023-06-29 | Traditional | PDF ↗ |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 | Traditional | PDF ↗ |
| K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022-09-23 | Traditional | PDF ↗ |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | 2021-04-29 | Traditional | PDF ↗ |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | 2021-03-30 | Special | PDF ↗ |
| K203085 | NOVA Patient Warming System | Encompass Group, LLC | 2020-11-12 | Traditional | PDF ↗ |
| K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020-09-11 | Special | PDF ↗ |
| K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | 2020-09-04 | Traditional | PDF ↗ |
| K200446 | STERIS Patient Warming System | STERIS Corporation | 2020-06-13 | Abbreviated | PDF ↗ |
| K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020-02-28 | Special | PDF ↗ |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019-10-25 | Traditional | PDF ↗ |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | 2019-05-02 | Special | PDF ↗ |
| K180834 | Altrix Precision Temperature Management System | Stryker Medical | 2018-08-10 | Traditional | PDF ↗ |
| K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K180375 | The IQoolTM Warm System | Braincool AB | 2018-05-18 | Traditional | PDF ↗ |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | 2017-10-10 | Traditional | PDF ↗ |
| K171149 | Altrix Temperature Management Wraps | Stryker Medical | 2017-07-18 | Traditional | PDF ↗ |
| K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017-05-26 | Special | PDF ↗ |
| K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K162562 | OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY | Bcg Medical, LLC | 2017-03-17 | Traditional | PDF ↗ |
| K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016-12-02 | Traditional | PDF ↗ |
| K161602 | Arctic Sun Temperature Management System | Medivance, Inc. | 2016-09-02 | Special | PDF ↗ |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | Medivance, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K140078 | TECOTHERM NEO (T NEO) | Inspiration Healthcare, Ltd. | 2014-11-14 | Abbreviated | PDF ↗ |
| K141686 | EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY | Smith Medical Asd, Inc. | 2014-10-28 | Traditional | PDF ↗ |
| K140635 | COCOON CONVECTIVE WARMING SYSTEM | Care Essentials Pty, Ltd. | 2014-07-25 | Traditional | PDF ↗ |
| K132048 | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET | Molnlycke Health Care Us, LLC | 2013-11-06 | Traditional | PDF ↗ |
| K132454 | VITAHEAT PATIENT WARMING SYSTEM | Vitaheat Medical, LLC | 2013-10-04 | Traditional | PDF ↗ |
| K131361 | WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET | Covidien | 2013-07-29 | Traditional | PDF ↗ |
| K123083 | COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT | Covidien | 2013-04-17 | Traditional | PDF ↗ |
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS | Cincinnati Sub-Zero Products, Inc. | 2013-01-17 | Special | PDF ↗ |
| K113705 | PINTLER PATIENT WARMING SYSTEM | Pintler Medical | 2012-08-31 | Traditional | PDF ↗ |
| K121720 | WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM | Welkins, LLC | 2012-08-20 | Traditional | PDF ↗ |
| K120849 | HYBRID ARCTICGEL PAD | Medivance, Inc. | 2012-07-20 | Traditional | PDF ↗ |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) | Cincinnati Sub-Zero Products, Inc. | 2012-07-03 | Special | PDF ↗ |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | Cincinnati Sub-Zero Products, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K112488 | HOTDOG PATIENT WARMING SYSTEM | Augustine Biomedical & Design, LLC | 2011-11-23 | Traditional | PDF ↗ |
| K102856 | SIROCCO THERMAL REGULATING SYSTEM | Galmaz Biotech S.L. | 2011-06-30 | Traditional | PDF ↗ |
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM | Cincinnati Sub-Zero Products, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011-01-20 | Traditional | PDF ↗ |
| K102112 | CRITICOOL PRO | Mtre Advanced Technology , Ltd. | 2010-11-18 | Traditional | PDF ↗ |
| K093244 | UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX | Geratherm Medical AG | 2010-10-19 | Traditional | PDF ↗ |
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS | Cincinnati Sub-Zero Products, Inc. | 2010-10-01 | Traditional | PDF ↗ |
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS | Cincinnati Sub-Zero Products, Inc. | 2010-09-20 | Traditional | PDF ↗ |
| K093694 | GERATHERM UNIQUERESC | Geratherm Medical AG | 2010-09-20 | Traditional | PDF ↗ |
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 | Medivance, Inc. | 2010-07-16 | Traditional | PDF ↗ |
| K101705 | MISTRAL-AIR WARMING SYSTEM | The Surgical Company International B.V. | 2010-07-02 | Traditional | PDF ↗ |
| K094056 | HOTDOG MULTI FUNCTION CONTROLLER | Augustine Biomedical & Design, LLC | 2010-06-03 | Traditional | PDF ↗ |
| K092807 | HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 | Augustine Biomedical & Design, LLC | 2009-12-10 | Traditional | PDF ↗ |
| K083336 | LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL | Smiths Medical Asd, Inc. | 2009-06-03 | Traditional | PDF ↗ |
| K083662 | CRITICOOL | Mtre Advanced Technology , Ltd. | 2009-03-26 | Traditional | PDF ↗ |
| K083135 | MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 | Thermogear, Inc. | 2008-10-31 | Traditional | PDF ↗ |
| K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 | Adroit Medical Systems, Inc. | 2008-06-06 | Traditional | PDF ↗ |
| K080763 | TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT | Talley Medical | 2008-05-30 | Traditional | PDF ↗ |
| K072513 | DM-EMG | Gvp Elettronica Srl | 2007-12-07 | Traditional | PDF ↗ |
| K071918 | CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 | Thermogear, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | Medivance, Inc. | 2007-08-03 | Special | PDF ↗ |
| K070112 | RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM | Medcool, Inc. | 2007-07-13 | Traditional | PDF ↗ |
| K061902 | COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 | Inditherm Medical | 2006-12-08 | Traditional | PDF ↗ |
| K062794 | PRN THERMALCARE, MODEL 3000 | American Healthcare Products, Inc. | 2006-12-07 | Traditional | PDF ↗ |
| K061513 | LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET | Smiths Medical Asd, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K051336 | GERATHERM SOS-RESCUE BAG | R.G. Enterprises, Inc. | 2006-06-29 | Traditional | PDF ↗ |
| K051278 | GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) | Rg Ent., Inc. | 2006-06-29 | Traditional | PDF ↗ |
| K052392 | HOT DOG PATIENT WARMING SYSTEM | Augustine Biomedical & Design, LLC | 2006-05-04 | Traditional | PDF ↗ |
| K051419 | INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 | Inditherm Medical | 2006-04-27 | Traditional | PDF ↗ |
| K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | Arizant Healthcare, Inc. | 2006-04-24 | Special | PDF ↗ |
| K053645 | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS | Arizant Healthcare, Inc. | 2006-03-09 | Special | PDF ↗ |
| K051097 | GERATHERM SOS-RESCUE BLANKET | Rg Ent., Inc. | 2006-02-24 | Traditional | PDF ↗ |
| K031728 | KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET | Klimamed Technologie Medizingerate GmbH | 2004-10-12 | Traditional | PDF ↗ |
| K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | Arizant Healthcare, Inc. | 2004-06-30 | Special | PDF ↗ |
| K040911 | VITALHEAT | Dynatherm Medical, Inc. | 2004-06-22 | Traditional | PDF ↗ |
| K040440 | HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) | Http Hypothermia Therapy | 2004-04-27 | Traditional | PDF ↗ |
| K040632 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 | Smiths Medical Asd, Inc. | 2004-04-27 | Special | PDF ↗ |
| K033021 | KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS | Kimberly-Clark Corp. | 2003-11-12 | Traditional | PDF ↗ |
| K024128 | ALLON 2001 VERSION 5 | Mtre Advanced Technology , Ltd. | 2003-02-10 | Special | PDF ↗ |
| K023934 | RAPID THERMAL EXCHANGE SYSTEM | Avacore Technologies, Inc. | 2003-01-23 | Traditional | PDF ↗ |
| K022903 | CHILLBUSTER | Microtek Medical, Inc. | 2002-11-27 | Traditional | PDF ↗ |
| K014210 | PALMO THERMOREGULATION INTERFACE ACCESSORY | Avacore Technologies, Inc. | 2002-08-16 | Traditional | PDF ↗ |
| K021473 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | Augustine Medical, Inc. | 2002-07-09 | Traditional | PDF ↗ |
| K011859 | KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS | Klimamed Technologie Medizingerate GmbH | 2002-05-01 | Traditional | PDF ↗ |
| K020604 | WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 | Nellcor Puritan Bennett, Inc. | 2002-04-23 | Special | PDF ↗ |
| K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 | Nellcor Puritan Bennett, Inc. | 2002-01-11 | Special | PDF ↗ |
| K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM | Sims Level 1, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 | Medivance, Inc. | 2001-03-07 | Special | PDF ↗ |
| K003368 | ACROTHERM | Aquarius Medical Corp. | 2001-01-19 | Traditional | PDF ↗ |
Product code DWJ · Class II · Cardiovascular. Data: openFDA.