DWJ · System, Thermal Regulating

Cardiovascular · 21 CFR 870.5900 · Class 2

Overview

Product CodeDWJ
Device NameSystem, Thermal Regulating
Regulation21 CFR 870.5900
Device ClassClass 2
Review PanelCardiovascular
3rd-Party ReviewableYes

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 158)

Showing 20 most recent of 158 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K260903Hot Pink Pad Warming SystemXodus Medical, Inc.Apr 16, 2026SESE
K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.Apr 7, 2026SESE
K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.Oct 24, 2025SESE
K242964Celsi WarmerHadleigh Health TechnologiesJun 20, 2025SESE
K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.Apr 30, 2025SESE
K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLCApr 18, 2024SESE
K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.Feb 21, 2024SESE
K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LPDec 1, 2023SESE
K232638FilteredFlo Warming BlanketsIob Medical, Inc.Oct 24, 2023SESE
K232844The IQoolTM SystemBraincool ABOct 4, 2023SESE
K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLCSep 15, 2023SESE
K231596IOB Temperature Management SystemIob Medical, Inc.Jun 30, 2023SESE
K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLCJun 29, 2023SESE
K221669IOB Warming BlanketsIob Medical, Inc.Dec 27, 2022SESE
K220941HotDog Temperature Management SystemAugustine Temperature ManagementSep 23, 2022SESE
K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M CompanyApr 29, 2021SESE
K2106033M Bair Hugger Temperature Management System (Model 675)3M CompanyMar 30, 2021SESE
K203085NOVA Patient Warming SystemEncompass Group, LLCNov 12, 2020SESE
K201779HotDog Temperature Management ControllerAugustine Temperature ManagementSep 11, 2020SESE
K202197Astopad Patient Warming SystemStihler Electronic GmbHSep 4, 2020SESE

Top Applicants

Innolitics

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