PMA · Approved
Recalled · Class I · 2012Olympic Cool-Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated · MXM Cap, Cooling (Infants)
Approved on Dec 20, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 936-day review. It has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Dec 20, 2006
- Review
- 936 days
- Class
- Class III
- Product code
- MXM
- Recalls
- 2 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040025 has 10 supplements since 2007: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2012 | Class II | Z-1843-2012 | Component design/selection | 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 continue cooling treatment. |
| May 9, 2012 | Class I | Z-0447-2013 | Nonconforming Material/Component | 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 treatment to the infants. The visible clock… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MXM devicesMXM Cap, Cooling (Infants): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXM
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MXM
Too few MXM 510(k)s in any year since 2007 to give a median.
Recalls per year · MXM
1in 2012
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MXM
1in 2020
MAUDE reports naming product code MXM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 1 | — | 1 (1) | 3 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P040025 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040025: Olympic Cool-Cap.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040025
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026