# K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Biomedical & Design, LLC
- Decided: Dec 10, 2009 after 90 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 K011859 (2002). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051419: Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1, Inditherm Medical (2006) Summary page 1.
- K052392: Hot Dog Patient Warming System, Augustine Biomedical & Design, LLC (2006) Summary page 1.
- K960167: System, Thermal Regulating 74-DWJ, Augustine Medical, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K094056: Hotdog Multi Function Controller (2010), 4 descendants of its own
- 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 Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad. 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/K092807
Methodology: https://510kreport.com/methodology