# FXP: Cover, Shoe, Operating-Room

- Device class: 1; regulation: 21 CFR 878.4040; FDA's rule: 510(k) exempt
- FDA decisions: 36
- 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)
- 1987: 3
- 1988: 4
- 1989: 2
- 1991: 1
- 1993: 2
- 1994: 1
- 1995: 3
- 1996: 2
- 1997: 2
- 1998: 1

## Most-cited predicates
- K914702: Sterile View (TM) Knee-High Boots/Depuy Shoe Boots (1993), cited by 1

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