# K094056: Hotdog Multi Function Controller

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Biomedical & Design, LLC
- Decided: Jun 3, 2010 after 154 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 K011859 (2002). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 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.
- K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103, Augustine Biomedical & Design, LLC (2009) Summary page 1.

## Most influential descendants
- K201779: HotDog Temperature Management Controller (2020), 3 descendants of its own
- K220941: HotDog Temperature Management System (2022), 2 descendants of its own
- K230866: HotDog Warming Mattress + Return Electrode (2023), 1 descendant of its own
- K232627: HotDog Warming Mattress + Return Electrode (2024), 0 descendants of its own

## Indications for use
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction Controller should be used in circumstances in which patients may not maintain a state of normothermia. 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/K094056
Methodology: https://510kreport.com/methodology