# OYS: Patient Bed With Canopy/Restraints

- Device class: 1; regulation: 21 CFR 880.6760; FDA's rule: 510(k) exempt
- FDA decisions: 3
- 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)
- 2011: 1
- 2012: 2

## Most-cited predicates
- K103817: Posey Bed (2011), cited by 2

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