# K180375: The IQoolTM Warm System

- Pathway: 510(k) (Traditional)
- Applicant: Braincool AB
- Decided: May 18, 2018 after 95 days
- Product code: DWJ (System, Thermal Regulating)
- 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 K811742 (1981). 5 ancestors in all.
1 later device descends 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)
- K101092: Arctic Sun Temperature Management System, Model 5000, Medivance, Inc. (2010) Summary page 4.

## Most influential descendants
- K232844: The IQoolTM System (2023), 0 descendants of its own

## Indications for use
The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.

Source page: https://510kreport.com/device/K180375
Methodology: https://510kreport.com/methodology