# MXM: Cap, Cooling (Infants)

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2007: 1
- 2008: 2
- 2009: 2
- 2010: 2
- 2012: 1
- 2013: 2

## Most-cited predicates

Source page: https://510kreport.com/product-code/MXM
Data by year (CSV): https://510kreport.com/product-code/MXM.csv