FDA product code · Neurology
Cap, Cooling (Infants)
1 FDA decision since 2006. 1 recall names this code; it is Class I.
Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MXM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in MXM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report