# K970367: Thermo-Stat System

- Pathway: 510(k) (Traditional)
- Applicant: Aquarius Medical Corp.
- Decided: Dec 17, 1997 after 320 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rewarming devices legally marketed by Augustine Medical: named in the summary without a submission number
- (no number) Rewarming devices legally marketed by MityVac: named in the summary without a submission number
- (no number) Rewarming devices legally marketed by Prism Technologies: named in the summary without a submission number

## Most influential descendants
- K040911: Vitalheat (2004), 0 descendants of its own

## Indications for use
The Thermo-STAT is designed to non-invasively treat hypothermic patients by rewarming their body core. This is accomplished with local application of negative pressure and a thermal load (heat) to a distal appendage.

Source page: https://510kreport.com/device/K970367
Methodology: https://510kreport.com/methodology