ClearanceBrief
Panels › Cardiovascular › Product code DWJ · Class 2

System, Thermal Regulating

Regulation 870.5900

5510(k)s in 12 months (161 all time)
3recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DWJ

Company510(k)sRecalls
Cincinnati Sub-Zero Products, Inc.914
Augustine Temperature Management413
Medivance, Inc.103
Augustine Medical, Inc.120
C.R. Bard, Inc.07
Gaymar Industries, Inc.60
Mtre Advanced Technology , Ltd.60
Smiths Medical Asd, Inc.42
Arizant Inc05
Care Essentials Pty, Ltd.32
Decided510(k)Device and applicantCode
Aug 21, 2026K262089Disposable Warming Blanket
Hangzhou Tappa Medical Technology Co., Ltd., CN
DWJ
Aug 7, 2026K261437Mistral-Air® Warming System
The Surgical Company International B.V., doing business as TSC Life, NL
DWJ
Jul 8, 2026K260278ThermAffyx(TM) Patient Safety System
Stihler Electronic GmbH, DE
DWJ
Apr 16, 2026K260903Hot Pink Pad Warming System
Xodus Medical, Inc.
DWJ
Apr 7, 2026K252861Warming System
Hangzhou Tappa Medical Technology Co., Ltd., CN
DWJ
Oct 24, 2025K251974Arctic Sun Temperature Management System (Model 5000)
Medivance, Inc.
DWJ
Jun 20, 2025K242964Celsi Warmer
Hadleigh Health Technologies
DWJ
Apr 30, 2025K243942Arctic Sun Stat Temperature Management System
Medivance, Inc.
DWJ
Apr 18, 2024K232627HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, LLC
DWJ
Feb 21, 2024K232502Cocoon Convective Warming System, Model CWS7000
Care Essentials Pty, Ltd., AU
DWJ
Dec 1, 2023K231211Medline ComfortTemp Patient Warming System
Medline Industries, LP
DWJ
Oct 24, 2023K232638FilteredFlo Warming Blankets
Iob Medical, Inc.
DWJ
Oct 4, 2023K232844The IQoolTM System
Braincool AB, SE
DWJ
Sep 15, 2023K232508Barrier EasyWarm Active Self-Warming Blanket
Molnlycke Health Care Us, LLC
DWJ
Jun 30, 2023K231596IOB Temperature Management System
Iob Medical, Inc.
DWJ
Jun 29, 2023K230866HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, LLC
DWJ
Dec 27, 2022K221669IOB Warming Blankets
Iob Medical, Inc.
DWJ
Sep 23, 2022K220941HotDog Temperature Management System
Augustine Temperature Management
DWJ
Apr 29, 2021K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
3M Company
DWJ
Mar 30, 2021K2106033M Bair Hugger Temperature Management System (Model 675)
3M Company
DWJ
Nov 12, 2020K203085NOVA Patient Warming System
Encompass Group, LLC
DWJ
Sep 11, 2020K201779HotDog Temperature Management Controller
Augustine Temperature Management
DWJ
Sep 4, 2020K202197Astopad Patient Warming System
Stihler Electronic GmbH, DE
DWJ
Jun 13, 2020K200446STERIS Patient Warming System
STERIS Corporation
DWJ
Feb 28, 2020K200225Arctic Sun Stat Temperature Management System
Medivance, Inc.
DWJ
Oct 25, 2019K190221IOB Warming Blankets
Iob Medical, Inc.
DWJ
May 2, 2019K181671Cocoon Convective Warming System
Care Essentials Pty, Ltd., AU
DWJ
Aug 10, 2018K180834Altrix Precision Temperature Management System
Stryker Medical
DWJ
Jul 26, 2018K181699Level 1 Convective Warmer
Smiths Medical Asd, Inc.
DWJ
May 18, 2018K180375The IQoolTM Warm System
Braincool AB, SE
DWJ
Oct 10, 2017K1713733M Bair Hugger Model 675 Total Temperature Management System
3M Company
DWJ
Jul 18, 2017K171149Altrix Temperature Management Wraps
Stryker Medical
DWJ
May 26, 2017K171234Mistral-Air Warming Unit
The Surgical Company International BV (As the 37company), NL
DWJ
Apr 28, 2017K162679IOB Temperature Management System
Iob Medical, Inc.
DWJ
Mar 17, 2017K162562OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
Bcg Medical, LLC
DWJ
Dec 2, 2016K152266Altrix Precision Temperature Management System
Stryker Medical
DWJ
Sep 2, 2016K161602Arctic Sun Temperature Management System
Medivance, Inc.
DWJ
Dec 18, 2014K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad
Medivance, Inc.
DWJ
Nov 14, 2014K140078TECOTHERM NEO (T NEO)
Inspiration Healthcare, Ltd., GB
DWJ
Oct 28, 2014K141686EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
Smith Medical Asd, Inc.
DWJ
Jul 25, 2014K140635COCOON CONVECTIVE WARMING SYSTEM
Care Essentials Pty, Ltd., AU
DWJ
Nov 6, 2013K132048BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
Molnlycke Health Care Us, LLC
DWJ
Oct 4, 2013K132454VITAHEAT PATIENT WARMING SYSTEM
Vitaheat Medical, LLC
DWJ
Jul 29, 2013K131361WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
Covidien
DWJ
Apr 17, 2013K123083COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
Covidien
DWJ
Jan 17, 2013K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
Cincinnati Sub-Zero Products, Inc.
DWJ
Aug 31, 2012K113705PINTLER PATIENT WARMING SYSTEM
Pintler Medical
DWJ
Aug 20, 2012K121720WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
Welkins, LLC
DWJ
Jul 20, 2012K120849HYBRID ARCTICGEL PAD
Medivance, Inc.
DWJ
Jul 3, 2012K121669WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Cincinnati Sub-Zero Products, Inc.
DWJ

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