# K261437: Mistral-Air® Warming System

- Pathway: 510(k) (Special)
- Applicant: The Surgical Company International B.V., doing business as TSC Life
- Decided: Aug 7, 2026 after 99 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942599 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171234: Mistral-Air Warming Unit, The Surgical Company International BV (As the 37company) (2017) Summary page 5.

## Indications for use
The Mistral-Air® Warming System is indicated for patient warming in situations where prevention of inadvertent hypothermia is required.

Source page: https://510kreport.com/device/K261437
Methodology: https://510kreport.com/methodology