# K220941: HotDog Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Temperature Management
- Decided: Sep 23, 2022 after 176 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: 6 generations back to K011859 (2002). 11 ancestors in all.
2 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)
- K201779: HotDog Temperature Management Controller, Augustine Temperature Management (2020) Summary page 4.

## Most influential descendants
- K230866: HotDog Warming Mattress + Return Electrode (2023), 1 descendant of its own
- K232627: HotDog Warming Mattress + Return Electrode (2024), 0 descendants of its own

## Recalls of this device
- Dec 4, 2024 · Class II · Z-0700-2025: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST"
- Dec 4, 2024 · Class II · Z-0701-2025: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST"
- Dec 4, 2024 · Class II · Z-0702-2025: Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST"
- Mar 14, 2022 · Class II · Z-0839-2025: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

## 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 and pediatric 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.

Source page: https://510kreport.com/device/K220941
Methodology: https://510kreport.com/methodology