# K210727: HotDog Warming Mattress + Return Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Augustine Temperature Management, LLC
- Decided: Feb 1, 2022 after 327 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K822572 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
5 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133726: Mega Soft Universal Patient Return Electrode, Megadyne Medical Products, Inc. (2014) Summary page 4.

## Recalls of this device
- 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 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/K210727
Methodology: https://510kreport.com/methodology