# K260903: Hot Pink Pad Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Xodus Medical, Inc.
- Decided: Apr 16, 2026 after 29 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: 5 generations back to K991684 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202197: Astopad Patient Warming System, Stihler Electronic GmbH (2020) Summary page 5.

## Indications for use
The Hot Pink Pad Warming System is a non-sterile, electrically conductive patient warming system with adjustable temperature in a predefined range. The Hot Pink Pad Warming System is to be used during surgical procedures to assist in patient temperature management and prevent inadvertent hypothermia. The Hot Pink Pad Warming System is intended for use in hospitals and surgery centers. The Hot Pink Pad Warming System's patient population includes adult and pediatric patients, but excludes neonatal patients.

Source page: https://510kreport.com/device/K260903
Methodology: https://510kreport.com/methodology