DWJ — System, Thermal Regulating Class II
FDA product code DWJ covers "System, Thermal Regulating", a Class II medical device regulated under 21 CFR 870.5900. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWJ
- Device Class
- Class II
- Regulation Number
- 870.5900
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260278 | stihler electronic | ThermAffyx(TM) Patient Safety System | July 8, 2026 |
| K260903 | xodus medical | Hot Pink Pad Warming System | April 16, 2026 |
| K252861 | hangzhou tappa medical technology co | Warming System | April 7, 2026 |
| K251974 | medivance | Arctic Sun Temperature Management System (Model 5000) | October 24, 2025 |
| K242964 | hadleigh health technologies | Celsi Warmer | June 20, 2025 |
| K243942 | medivance | Arctic Sun Stat Temperature Management System | April 30, 2025 |
| K232627 | augustine temperature management | HotDog Warming Mattress + Return Electrode | April 18, 2024 |
| K232502 | care essentials pty | Cocoon Convective Warming System, Model CWS7000 | February 21, 2024 |
| K231211 | medline industries | Medline ComfortTemp Patient Warming System | December 1, 2023 |
| K232638 | iob medical | FilteredFlo Warming Blankets | October 24, 2023 |
| K232844 | braincool | The IQoolTM System | October 4, 2023 |
| K232508 | molnlycke health care us | Barrier EasyWarm Active Self-Warming Blanket | September 15, 2023 |
| K231596 | iob medical | IOB Temperature Management System | June 30, 2023 |
| K230866 | augustine temperature management | HotDog Warming Mattress + Return Electrode | June 29, 2023 |
| K221669 | iob medical | IOB Warming Blankets | December 27, 2022 |
| K220941 | augustine temperature management | HotDog Temperature Management System | September 23, 2022 |
| K210605 | 3m | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | April 29, 2021 |
| K210603 | 3m | 3M Bair Hugger Temperature Management System (Model 675) | March 30, 2021 |
| K203085 | encompass group | NOVA Patient Warming System | November 12, 2020 |
| K201779 | augustine temperature management | HotDog Temperature Management Controller | September 11, 2020 |