# K942790: Warm Air Hypertheermia System (Models #130 and #133)

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Jan 24, 1995 after 225 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.
6 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101148: Warm Air Model 135 Hyperthermia System and Blankets (2010), 2 descendants of its own
- K101705: Mistral-Air Warming System (2010), 2 descendants of its own
- K171234: Mistral-Air Warming Unit (2017), 1 descendant of its own
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets) (2012), 1 descendant of its own
- K261437: Mistral-Air® Warming System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K942790
Methodology: https://510kreport.com/methodology