# KME: Bedding, Disposable, Medical

- Device class: 1; regulation: 21 CFR 880.6060; FDA's rule: 510(k) exempt
- FDA decisions: 65
- Recalls: 1 (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)
- 1986: 3
- 1987: 4
- 1988: 4
- 1989: 2
- 1990: 6
- 1991: 5
- 1992: 2
- 1993: 1
- 1994: 2
- 2004: 1

## Most-cited predicates

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