# K232844: The IQoolTM System

- Pathway: 510(k) (Special)
- Applicant: Braincool AB
- Decided: Oct 4, 2023 after 20 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: 4 generations back to K811742 (1981). 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)
- K180375: The IQoolTM Warm System, Braincool AB (2018) Summary page 5.

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

Source page: https://510kreport.com/device/K232844
Methodology: https://510kreport.com/methodology