# K101705: Mistral-Air Warming System

- Pathway: 510(k) (Traditional)
- Applicant: The Surgical Company International B.V.
- Decided: Jul 2, 2010 after 15 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942599 (1995). 4 ancestors in all.
2 later devices descend 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)
- K073712: Soft Air, Model SA 4000 and Mistral Air, Model MA0100, Adroit Medical Systems, Inc. (2008) Summary page 1.
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000)
- K942599: Warm Air Warming Unit, Cincinnati Sub-Zero Products, Inc. (1995) Summary page 1.
- K942790: Warm Air Hypertheermia System (Models #130 and #133), Cincinnati Sub-Zero Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K171234: Mistral-Air Warming Unit (2017), 1 descendant of its own
- K261437: Mistral-Air® Warming System (2026), 0 descendants of its own

## Recalls of this device
- Jul 21, 2017 · Class II · Z-0419-2018: It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the b

## 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/K101705
Methodology: https://510kreport.com/methodology