# FSM: Tray, Surgical, Instrument

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 76
- Recalls: 23 (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: 2
- 1986: 6
- 1987: 5
- 1988: 3
- 1989: 1
- 1990: 3
- 1991: 8
- 1994: 1
- 1996: 1
- 1997: 1

## Most-cited predicates
- K944025: Surgical Instrument Tray (1994), cited by 4
- K844002: HU-Friedy Ims Cassette System (1984), cited by 2
- K844652: C.a.S.E. Container (1984), cited by 2
- K770428: Various Surg. & Diagnostic Instru. Etc. (1979), cited by 1

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