# K260278: ThermAffyx (TM) Patient Safety System

- Pathway: 510(k) (Traditional)
- Applicant: Stihler Electronic GmbH
- Decided: Jul 8, 2026 after 160 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.
- (no number) PrimePad®: named in the summary without a submission number

## Indications for use
The ThermAffyx(TM) Patient Safety System is intended to maintain normothermia, treat hypothermia and provide anti-slip positioning securement for patients. The system is intended to be used by trained healthcare professionals in all areas of professional healthcare facilities. It is indicated for use on adult patients.

Source page: https://510kreport.com/device/K260278
Methodology: https://510kreport.com/methodology