# K132454: Vitaheat Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Vitaheat Medical, LLC
- Decided: Oct 4, 2013 after 59 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: 4 generations back to K011859 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103, Augustine Biomedical & Design, LLC (2009) Summary page 5.

## Indications for use
The VITAHEAT Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The VITAHEAT Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.

Source page: https://510kreport.com/device/K132454
Methodology: https://510kreport.com/methodology