FDA product code MXM: Cap, Cooling (Infants)
MXM is the FDA product code for cap, cooling (infants). It is a Class III device, reviewed by the Neurology panel. Devices under MXM reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for MXM devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Cap, Cooling (Infants) |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MXM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-05-21.
Frequently asked questions
What is FDA product code MXM?
MXM is the FDA product code for cap, cooling (infants). It is a Class III device, reviewed by the Neurology panel.
What device class is MXM?
Class III. Typical premarket route: PMA.
Have MXM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MXM
- Run a recall and safety report across every MXM manufacturer
- Watch product code MXM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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