# FTA: Light, Surgical, Accessories

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) exempt
- FDA decisions: 26
- Recalls: 4 (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)
- 1999: 1
- 2002: 2
- 2003: 1
- 2005: 1
- 2006: 1
- 2008: 1
- 2010: 1
- 2012: 1
- 2014: 3
- 2015: 1

## Most-cited predicates
- K102791: Easysuite Surgical Light Control (Eslc) (2010), cited by 2
- K020640: Ksea SCB Media Control (2002), cited by 2
- K023704: Ksea SCB Acc Control (2003), cited by 1
- K915068: Plastic Disposable Surgical Light Handle Cover (1992), cited by 1
- K901154: Microtek's Surgical Lamp Handle & Cover (1990), cited by 1
- K081698: Mainstream or Surgical Light Control (MSLC) (2008), cited by 1
- K051505: SCB/Steris or-Light Interface Box (2005), cited by 1

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