# K112488: Hotdog Patient Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Biomedical & Design, LLC
- Decided: Nov 23, 2011 after 86 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: 3 generations back to K991684 (2000). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052392: Hot Dog Patient Warming System, Augustine Biomedical & Design, LLC (2006) Summary page 1.

## Most influential descendants
- K202197: Astopad Patient Warming System (2020), 2 descendants of its own
- K132048: Barrier Easywarm Active Self-Warming Blanket (2013), 1 descendant of its own
- K260278: ThermAffyx (TM) Patient Safety System (2026), 0 descendants of its own
- K260903: Hot Pink Pad Warming System (2026), 0 descendants of its own
- K232508: Barrier EasyWarm Active Self-Warming Blanket (2023), 0 descendants of its own

## Indications for use
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.

Source page: https://510kreport.com/device/K112488
Methodology: https://510kreport.com/methodology