# K073712: Soft Air, Model SA 4000 and Mistral Air, Model MA0100

- Pathway: 510(k) (Traditional)
- Applicant: Adroit Medical Systems, Inc.
- Decided: Jun 6, 2008 after 158 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101705: Mistral-Air Warming System (2010), 2 descendants of its own
- K171234: Mistral-Air Warming Unit (2017), 1 descendant of its own
- K261437: Mistral-Air® Warming System (2026), 0 descendants of its own

## Indications for use
The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.

Source page: https://510kreport.com/device/K073712
Methodology: https://510kreport.com/methodology