DWJ — System, Thermal Regulating Class II
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 |
|---|---|---|---|
| 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 |
| K202197 | stihler electronic | Astopad Patient Warming System | September 4, 2020 |
| K200446 | steris corporation | STERIS Patient Warming System | June 13, 2020 |
| K200225 | medivance | Arctic Sun Stat Temperature Management System | February 28, 2020 |