# FSS: Light, Surgical, Floor Standing

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) exempt
- FDA decisions: 20
- 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)
- 1988: 3
- 1989: 4
- 1991: 1
- 1993: 1
- 1996: 2
- 1997: 1
- 1998: 4
- 1999: 1
- 2001: 1
- 2009: 1

## Most-cited predicates
- K961971: Q-5000 (1996), cited by 2
- K981962: Cuda Products Corp. Model M300 (M-300) Lightsource (1998), cited by 2
- K961074: Lightsource or Illuminator (1996), cited by 1
- K003489: Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 (2001), cited by 1
- K970886: Hanaulux Blue 80 Hospital (1997), cited by 1
- K980044: Xenon 300MX (1998), cited by 1

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