# K232627: HotDog Warming Mattress + Return Electrode

- Pathway: 510(k) (Special)
- Applicant: Augustine Temperature Management, LLC
- Decided: Apr 18, 2024 after 233 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: 8 generations back to K011859 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230866: HotDog Warming Mattress + Return Electrode, Augustine Temperature Management, LLC (2023) Summary page 4.

## 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 or two electrosurgical units (ESU) or generators 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/K232627
Methodology: https://510kreport.com/methodology