# MMA: Oximeter, Fetal Pulse

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 1
- 2001: 5
- 2002: 5
- 2003: 3
- 2005: 2

## Most-cited predicates

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