# FMS: Bed, Pediatric Open Hospital

- Device class: 2; regulation: 21 CFR 880.5140; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 3 (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)
- 1985: 3
- 1986: 5
- 1988: 3
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 3
- 1995: 4
- 1996: 3
- 1997: 1

## Most-cited predicates
- K901763: Nature's Cradle (TM) (1991), cited by 2
- K960747: Nature's Cradle Model C1500 (1996), cited by 1

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