# FNM: Mattress, Air Flotation, Alternating Pressure

- Device class: 2; regulation: 21 CFR 880.5550; FDA's rule: 510(k) exempt
- FDA decisions: 102
- Recalls: 6 (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)
- 1988: 6
- 1989: 3
- 1990: 4
- 1992: 4
- 1993: 8
- 1994: 9
- 1995: 17
- 1996: 14
- 1997: 14
- 1998: 4

## Most-cited predicates
- K953503: Pressureguard IV (1995), cited by 2
- K951112: Pressureguard IV (1995), cited by 2
- K944094: Triadyne (1995), cited by 1
- K960620: Pressureguard: Low Air Loss Mattress System (1996), cited by 1
- K930673: Premium (1993), cited by 1
- K952610: Plexus/3000 (P/3000), Plexus/3500 (P/3500) (1995), cited by 1

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