# K240933: CarbonCool® System

- Pathway: 510(k) (Traditional)
- Applicant: Global Healthcare SG Sdn. Bhd
- Decided: Mar 18, 2025 after 347 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.
No later device cites it as a predicate yet.
0 of 5 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 5.

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

Source page: https://510kreport.com/device/K240933
Methodology: https://510kreport.com/methodology