Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900) → DWJ — System, Thermal Regulating # DWJ · System, Thermal Regulating _Cardiovascular · 21 CFR 870.5900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ ## Overview - **Product Code:** DWJ - **Device Name:** System, Thermal Regulating - **Regulation:** [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260903](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K260903.md) | Hot Pink Pad Warming System | Xodus Medical, Inc. | Apr 16, 2026 | SESE | | [K252861](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K252861.md) | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | Apr 7, 2026 | SESE | | [K251974](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K251974.md) | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | Oct 24, 2025 | SESE | | [K242964](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K242964.md) | Celsi Warmer | Hadleigh Health Technologies | Jun 20, 2025 | SESE | | [K243942](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K243942.md) | Arctic Sun Stat Temperature Management System | Medivance, Inc. | Apr 30, 2025 | SESE | | [K232627](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K232627.md) | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | Apr 18, 2024 | SESE | | [K232502](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K232502.md) | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | Feb 21, 2024 | SESE | | [K231211](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K231211.md) | Medline ComfortTemp Patient Warming System | Medline Industries, LP | Dec 1, 2023 | SESE | | [K232638](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K232638.md) | FilteredFlo Warming Blankets | Iob Medical, Inc. | Oct 24, 2023 | SESE | | [K232844](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K232844.md) | The IQoolTM System | Braincool AB | Oct 4, 2023 | SESE | | [K232508](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K232508.md) | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | Sep 15, 2023 | SESE | | [K231596](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K231596.md) | IOB Temperature Management System | Iob Medical, Inc. | Jun 30, 2023 | SESE | | [K230866](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K230866.md) | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | Jun 29, 2023 | SESE | | [K221669](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K221669.md) | IOB Warming Blankets | Iob Medical, Inc. | Dec 27, 2022 | SESE | | [K220941](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K220941.md) | HotDog Temperature Management System | Augustine Temperature Management | Sep 23, 2022 | SESE | | [K210605](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K210605.md) | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | Apr 29, 2021 | SESE | | [K210603](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K210603.md) | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | Mar 30, 2021 | SESE | | [K203085](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K203085.md) | NOVA Patient Warming System | Encompass Group, LLC | Nov 12, 2020 | SESE | | [K201779](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K201779.md) | HotDog Temperature Management Controller | Augustine Temperature Management | Sep 11, 2020 | SESE | | [K202197](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ/K202197.md) | Astopad Patient Warming System | Stihler Electronic GmbH | Sep 4, 2020 | SESE | ## Top Applicants - Augustine Medical, Inc. — 12 clearances - Medivance, Inc. — 10 clearances - Cincinnati Sub-Zero Products, Inc. — 9 clearances - Gaymar Industries, Inc. — 6 clearances - Mtre Advanced Technology , Ltd. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com