FDA.report

Product code DWJ

Current FDA Classification

Device name
System, Thermal Regulating
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.5900
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
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).

Related 510(k) Records

510(k)DeviceApplicantDecision date
K260903Hot Pink Pad Warming SystemXodus Medical, Inc.2026-04-16
K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.2026-04-07
K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.2025-10-24
K242964Celsi WarmerHadleigh Health Technologies2025-06-20
K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.2025-04-30
K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2024-04-18
K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.2024-02-21
K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-01
K232638FilteredFlo Warming BlanketsIob Medical, Inc.2023-10-24
K232844The IQoolTM SystemBraincool AB2023-10-04
K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2023-09-15
K231596IOB Temperature Management SystemIob Medical, Inc.2023-06-30
K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2023-06-29
K221669IOB Warming BlanketsIob Medical, Inc.2022-12-27
K220941HotDog Temperature Management SystemAugustine Temperature Management2022-09-23
K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company2021-04-29
K2106033M Bair Hugger Temperature Management System (Model 675)3M Company2021-03-30
K203085NOVA Patient Warming SystemEncompass Group, LLC2020-11-12
K201779HotDog Temperature Management ControllerAugustine Temperature Management2020-09-11
K202197Astopad Patient Warming SystemStihler Electronic GmbH2020-09-04
K200446STERIS Patient Warming SystemSTERIS Corporation2020-06-13
K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.2020-02-28
K190221IOB Warming BlanketsIob Medical, Inc.2019-10-25
K181671Cocoon Convective Warming SystemCare Essentials Pty, Ltd.2019-05-02
K180834Altrix Precision Temperature Management SystemStryker Medical2018-08-10
K181699Level 1 Convective WarmerSmiths Medical Asd, Inc.2018-07-26
K180375The IQoolTM Warm SystemBraincool AB2018-05-18
K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company2017-10-10
K171149Altrix Temperature Management WrapsStryker Medical2017-07-18
K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)2017-05-26

Related GUDID Devices

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00197998156397Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998156373Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998156038Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998156014Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155994Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155970Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155956Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155932Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155918Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155871Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155116Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155093Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155079Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155055Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155031Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998155017Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998154997Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00197998154973Solventum™ Bair Hugger™Solventum US LLC2026-01-30
00614801000079Medical Warming SystemsR.G. ENTERPRISES (U.S.A.), INC.2025-07-09
00614801000062Medical Warming SystemsR.G. ENTERPRISES (U.S.A.), INC.2025-07-09
00850047646071CritiCool MiniBELMONT INSTRUMENT CORPORATION2024-04-16
10608223645007Bair Hugger™3M COMPANY2016-09-24
10608223630003Bair Hugger™3M COMPANY2016-09-24