# K020604: Warmtouch Patient Warming System, Model 5300

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Apr 23, 2002 after 57 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 K913016 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913016: Warmtouch, Advanced Warming Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K123083: Covidien Warmtouch Convective Warming Unit (2013), 0 descendants of its own

## Indications for use
The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

Source page: https://510kreport.com/device/K020604
Methodology: https://510kreport.com/methodology