# P040025: Olympic Cool-Cap

- Pathway: PMA
- Applicant: Natus Medical Incorporated
- Decided: Dec 20, 2006 after 936 days
- Product code: MXM (Cap, Cooling (Infants))
- Device class: 3
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 21, 2012 · Class II · Z-1843-2012: Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continu
- May 9, 2012 · Class I · Z-0447-2013: The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatmen

Source page: https://510kreport.com/device/P040025
Methodology: https://510kreport.com/methodology