Mistral-Air® Warming System
FDA 510(k) clearance K261437 · decided 2026-08-07
Clearance details
- K-number
- K261437
- Device name
- Mistral-Air® Warming System
- Applicant
- The Surgical Company International B.V., doing business as TSC Life
- Decision
- Substantially Equivalent
- Date received
- 2026-04-30
- Decision date
- 2026-08-07
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Amsterdam, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ThermAffyx(TM) Patient Safety System (K260278) | Stihler Electronic GmbH | 2026-07-08 |
| Hot Pink Pad Warming System (K260903) | Xodus Medical, Inc. | 2026-04-16 |
| Warming System (K252861) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| Arctic Sun Temperature Management System (Model 5000) (K251974) | Medivance, Inc. | 2025-10-24 |
| Celsi Warmer (K242964) | Hadleigh Health Technologies | 2025-06-20 |
| Arctic Sun Stat Temperature Management System (K243942) | Medivance, Inc. | 2025-04-30 |
| HotDog Warming Mattress + Return Electrode (K232627) | Augustine Temperature Management, LLC | 2024-04-18 |
| Cocoon Convective Warming System, Model CWS7000 (K232502) | Care Essentials Pty, Ltd. | 2024-02-21 |
| Medline ComfortTemp Patient Warming System (K231211) | Medline Industries, LP | 2023-12-01 |
| FilteredFlo Warming Blankets (K232638) | Iob Medical, Inc. | 2023-10-24 |
| The IQoolTM System (K232844) | Braincool AB | 2023-10-04 |
| Barrier EasyWarm Active Self-Warming Blanket (K232508) | Molnlycke Health Care Us, LLC | 2023-09-15 |
Recalls involving this device
No recalls on record reference this clearance.