# K942599: Warm Air Warming Unit

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Jan 24, 1995 after 237 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 3 (0 Class I)
- 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

## Recalls of this device
- Nov 14, 2009 · Not classified · Z-0781-2010: Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the 
- Feb 16, 2009 · Not classified · Z-0035-2010: The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing
- Nov 5, 2004 · Not classified · Z-0374-05: Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.

Source page: https://510kreport.com/device/K942599
Methodology: https://510kreport.com/methodology