# K100071: Emcoolspad

- Pathway: 510(k) (Traditional)
- Applicant: Emcools Emergency Medical Cooling Systems AG
- Decided: Oct 12, 2010 after 274 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: 2 generations back to K912051 (1991). 3 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010338: Artic Sun Temperature Management System, Model 200, Medivance, Inc. (2001) Summary page 1.
- K061023: Thermosuit System, Life Recovery Systems Hd, LLC (2006) Summary page 1.

## Most influential descendants
- K162523: The IQool System (2017), 2 descendants of its own
- K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (2023), 1 descendant of its own
- K250979: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (2025), 0 descendants of its own
- K240933: CarbonCool® System (2025), 0 descendants of its own
- K121720: Welkins Emt/Icu Temperature Managerment System (2012), 0 descendants of its own

## Indications for use
Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.

Source page: https://510kreport.com/device/K100071
Methodology: https://510kreport.com/methodology