# K162523: The IQool System

- Pathway: 510(k) (Traditional)
- Applicant: Braincool AB
- Decided: May 3, 2017 after 236 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: 3 generations back to K912051 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100071: Emcoolspad, Emcools Emergency Medical Cooling Systems AG (2010) Summary page 4.

## Most influential descendants
- 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

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

Source page: https://510kreport.com/device/K162523
Methodology: https://510kreport.com/methodology