# K250979: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation, Inc.
- Decided: Oct 15, 2025 after 198 days
- Product code: NZE (Hyperthermia Monitor)
- 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: 5 generations back to K912051 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System, Zoll Circulation, Inc. (2023) Summary page 5.

## Indications for use
When used with Thermogard XP® or Thermogard HQ™ console: Temperature reduction in patients 2 years and older where clinically indicated, e.g. in hyperthermic patients.

Source page: https://510kreport.com/device/K250979
Methodology: https://510kreport.com/methodology