# K252861: Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Tappa Medical Technology Co., Ltd.
- Decided: Apr 7, 2026 after 210 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 K021473 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231596: IOB Temperature Management System, Iob Medical, Inc. (2023) Summary page 5.

## Indications for use
The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Source page: https://510kreport.com/device/K252861
Methodology: https://510kreport.com/methodology