# K123083: Covidien Warmtouch Convective Warming Unit

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Apr 17, 2013 after 198 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
Longest line of descent: 2 generations back to K913016 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020604: Warmtouch Patient Warming System, Model 5300, Nellcor Puritan Bennett, Inc. (2002) Summary page 2.

## Indications for use
The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.

Source page: https://510kreport.com/device/K123083
Methodology: https://510kreport.com/methodology