# K230866: HotDog Warming Mattress + Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Temperature Management, LLC
- Decided: Jun 29, 2023 after 92 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011859 (2002). 12 ancestors in all.
1 later device descends 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)
- K220941: HotDog Temperature Management System, Augustine Temperature Management (2022) Summary page 4.

## Most influential descendants
- K232627: HotDog Warming Mattress + Return Electrode (2024), 0 descendants of its own

## Recalls of this device
- Dec 16, 2024 · Class II · Z-1197-2025: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience 
- Dec 16, 2024 · Class II · Z-1199-2025: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience 
- Feb 15, 2024 · Class II · Z-1172-2025: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Feb 15, 2024 · Class II · Z-1171-2025: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

## Indications for use
The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors. The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.

Source page: https://510kreport.com/device/K230866
Methodology: https://510kreport.com/methodology