# K202197: Astopad Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Stihler Electronic GmbH
- Decided: Sep 4, 2020 after 30 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 K991684 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112488: Hotdog Patient Warming System, Augustine Biomedical & Design, LLC (2011) Summary page 4.

## Most influential descendants
- K260278: ThermAffyx (TM) Patient Safety System (2026), 0 descendants of its own
- K260903: Hot Pink Pad Warming System (2026), 0 descendants of its own

## Indications for use
The ASTOPAD® Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The ASTOPAD Patient Warming System is indicated for use in all areas of healthcare facilities for preventing or treating hypothermia or maintaining normothermia. The warming blankets can be used over or under the patient (pediatric and adult) by appropriately trained healthcare professionals.

Source page: https://510kreport.com/device/K202197
Methodology: https://510kreport.com/methodology