# OUW: Infant Positioner, Rx, Use In Highly Monitored Setting

- Device class: 1; regulation: 21 CFR 880.5680; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 2 (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)
- 2018: 1

## Most-cited predicates

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