Atlas FDA

DWJ

160 FDA 510(k) clearances · Product code

106 daysmedian time to decision
305 days90th percentile
160clearances measured

FDA profile

Official device name
System, Thermal Regulating
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5900
Medical specialty
Cardiovascular
Flags
Third-party review eligible
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 2,689 · 2022: 3,226 · 2023: 3,455 · 2024: 3,329 · 2025: 2,431 · 2026: 1,078
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Mistral-Air® Warming System (K261437)The Surgical Company International B.V., doing business as TSC Life2026-08-07
ThermAffyx(TM) Patient Safety System (K260278)Stihler Electronic GmbH2026-07-08
Hot Pink Pad Warming System (K260903)Xodus Medical, Inc.2026-04-16
Warming System (K252861)Hangzhou Tappa Medical Technology Co., Ltd.2026-04-07
Arctic Sun Temperature Management System (Model 5000) (K251974)Medivance, Inc.2025-10-24
Celsi Warmer (K242964)Hadleigh Health Technologies2025-06-20
Arctic Sun Stat Temperature Management System (K243942)Medivance, Inc.2025-04-30
HotDog Warming Mattress + Return Electrode (K232627)Augustine Temperature Management, LLC2024-04-18
Cocoon Convective Warming System, Model CWS7000 (K232502)Care Essentials Pty, Ltd.2024-02-21
Medline ComfortTemp Patient Warming System (K231211)Medline Industries, LP2023-12-01
FilteredFlo Warming Blankets (K232638)Iob Medical, Inc.2023-10-24
The IQoolTM System (K232844)Braincool AB2023-10-04
Barrier EasyWarm Active Self-Warming Blanket (K232508)Molnlycke Health Care Us, LLC2023-09-15
IOB Temperature Management System (K231596)Iob Medical, Inc.2023-06-30
HotDog Warming Mattress + Return Electrode (K230866)Augustine Temperature Management, LLC2023-06-29
IOB Warming Blankets (K221669)Iob Medical, Inc.2022-12-27
HotDog Temperature Management System (K220941)Augustine Temperature Management2022-09-23
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation (K210605)3M Company2021-04-29
3M Bair Hugger Temperature Management System (Model 675) (K210603)3M Company2021-03-30
NOVA Patient Warming System (K203085)Encompass Group, LLC2020-11-12
HotDog Temperature Management Controller (K201779)Augustine Temperature Management2020-09-11
Astopad Patient Warming System (K202197)Stihler Electronic GmbH2020-09-04
STERIS Patient Warming System (K200446)STERIS Corporation2020-06-13
Arctic Sun Stat Temperature Management System (K200225)Medivance, Inc.2020-02-28
IOB Warming Blankets (K190221)Iob Medical, Inc.2019-10-25
Cocoon Convective Warming System (K181671)Care Essentials Pty, Ltd.2019-05-02
Altrix Precision Temperature Management System (K180834)Stryker Medical2018-08-10
Level 1 Convective Warmer (K181699)Smiths Medical Asd, Inc.2018-07-26
The IQoolTM Warm System (K180375)Braincool AB2018-05-18
3M Bair Hugger Model 675 Total Temperature Management System (K171373)3M Company2017-10-10
Altrix Temperature Management Wraps (K171149)Stryker Medical2017-07-18
Mistral-Air Warming Unit (K171234)The Surgical Company International BV (As the 37company)2017-05-26
IOB Temperature Management System (K162679)Iob Medical, Inc.2017-04-28
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY (K162562)Bcg Medical, LLC2017-03-17
Altrix Precision Temperature Management System (K152266)Stryker Medical2016-12-02
Arctic Sun Temperature Management System (K161602)Medivance, Inc.2016-09-02
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (K142702)Medivance, Inc.2014-12-18
TECOTHERM NEO (T NEO) (K140078)Inspiration Healthcare, Ltd.2014-11-14
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY (K141686)Smith Medical Asd, Inc.2014-10-28
COCOON CONVECTIVE WARMING SYSTEM (K140635)Care Essentials Pty, Ltd.2014-07-25
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET (K132048)Molnlycke Health Care Us, LLC2013-11-06
VITAHEAT PATIENT WARMING SYSTEM (K132454)Vitaheat Medical, LLC2013-10-04
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET (K131361)Covidien2013-07-29
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT (K123083)Covidien2013-04-17
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (K123946)Cincinnati Sub-Zero Products, Inc.2013-01-17
PINTLER PATIENT WARMING SYSTEM (K113705)Pintler Medical2012-08-31
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM (K121720)Welkins, LLC2012-08-20
HYBRID ARCTICGEL PAD (K120849)Medivance, Inc.2012-07-20
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (K121669)Cincinnati Sub-Zero Products, Inc.2012-07-03
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (K120081)Cincinnati Sub-Zero Products, Inc.2012-02-17
HOTDOG PATIENT WARMING SYSTEM (K112488)Augustine Biomedical & Design, LLC2011-11-23
SIROCCO THERMAL REGULATING SYSTEM (K102856)Galmaz Biotech S.L.2011-06-30
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (K110104)Cincinnati Sub-Zero Products, Inc.2011-02-04
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (K100585)Gaymar Industries, Inc.2011-01-20
CRITICOOL PRO (K102112)Mtre Advanced Technology , Ltd.2010-11-18
UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX (K093244)Geratherm Medical AG2010-10-19
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (K101148)Cincinnati Sub-Zero Products, Inc.2010-10-01
GERATHERM UNIQUERESC (K093694)Geratherm Medical AG2010-09-20
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (K101589)Cincinnati Sub-Zero Products, Inc.2010-09-20
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (K101092)Medivance, Inc.2010-07-16
MISTRAL-AIR WARMING SYSTEM (K101705)The Surgical Company International B.V.2010-07-02
HOTDOG MULTI FUNCTION CONTROLLER (K094056)Augustine Biomedical & Design, LLC2010-06-03
HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 (K092807)Augustine Biomedical & Design, LLC2009-12-10
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL (K083336)Smiths Medical Asd, Inc.2009-06-03
CRITICOOL (K083662)Mtre Advanced Technology , Ltd.2009-03-26
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 (K083135)Thermogear, Inc.2008-10-31
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (K073712)Adroit Medical Systems, Inc.2008-06-06
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT (K080763)Talley Medical2008-05-30
DM-EMG (K072513)Gvp Elettronica Srl2007-12-07
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 (K071918)Thermogear, Inc.2007-11-09
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (K071341)Medivance, Inc.2007-08-03
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM (K070112)Medcool, Inc.2007-07-13
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 (K061902)Inditherm Medical2006-12-08
PRN THERMALCARE, MODEL 3000 (K062794)American Healthcare Products, Inc.2006-12-07
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET (K061513)Smiths Medical Asd, Inc.2006-08-01
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) (K051278)Rg Ent., Inc.2006-06-29
GERATHERM SOS-RESCUE BAG (K051336)R.G. Enterprises, Inc.2006-06-29
HOT DOG PATIENT WARMING SYSTEM (K052392)Augustine Biomedical & Design, LLC2006-05-04
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 (K051419)Inditherm Medical2006-04-27
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (K060865)Arizant Healthcare, Inc.2006-04-24
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS (K053645)Arizant Healthcare, Inc.2006-03-09
GERATHERM SOS-RESCUE BLANKET (K051097)Rg Ent., Inc.2006-02-24
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET (K031728)Klimamed Technologie Medizingerate GmbH2004-10-12
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K041686)Arizant Healthcare, Inc.2004-06-30
VITALHEAT (K040911)Dynatherm Medical, Inc.2004-06-22
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) (K040440)Http Hypothermia Therapy2004-04-27
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 (K040632)Smiths Medical Asd, Inc.2004-04-27
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS (K033021)Kimberly-Clark Corp.2003-11-12
ALLON 2001 VERSION 5 (K024128)Mtre Advanced Technology , Ltd.2003-02-10
RAPID THERMAL EXCHANGE SYSTEM (K023934)Avacore Technologies, Inc.2003-01-23
CHILLBUSTER (K022903)Microtek Medical, Inc.2002-11-27
PALMO THERMOREGULATION INTERFACE ACCESSORY (K014210)Avacore Technologies, Inc.2002-08-16
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K021473)Augustine Medical, Inc.2002-07-09
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS (K011859)Klimamed Technologie Medizingerate GmbH2002-05-01
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 (K020604)Nellcor Puritan Bennett, Inc.2002-04-23
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 (K014121)Nellcor Puritan Bennett, Inc.2002-01-11
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM (K011907)Sims Level 1, Inc.2001-12-18
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (K010338)Medivance, Inc.2001-03-07
ACROTHERM (K003368)Aquarius Medical Corp.2001-01-19
ALLON 2001 MODIFIED (K003349)Mtre Advanced Technology , Ltd.2000-11-13
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