# K171234: Mistral-Air Warming Unit

- Pathway: 510(k) (Special)
- Applicant: The Surgical Company International BV (As the 37company)
- Decided: May 26, 2017 after 29 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: 2 generations back to K942599 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101705: Mistral-Air Warming System, The Surgical Company International B.V. (2010) Summary page 5.

## Most influential descendants
- K261437: Mistral-Air® Warming System (2026), 0 descendants of its own

## Indications for use
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming,.

Source page: https://510kreport.com/device/K171234
Methodology: https://510kreport.com/methodology