# K131361: Warmtouch Surgical Access Blanket, Warmtouch Torso Blanket

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jul 29, 2013 after 77 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: 1 generation back to K014121 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014121: Warmtouch Cardiac Blanket,Catalog # 503-0860, Nellcor Puritan Bennett, Inc. (2002)

## Indications for use
The WarmTouchTM Surgical Access Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers. The WannTouchTm Torso Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

Source page: https://510kreport.com/device/K131361
Methodology: https://510kreport.com/methodology