# FTD: Lamp, Surgical

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 32 (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)
- 1995: 1
- 1996: 1
- 1998: 1
- 2001: 3
- 2004: 1
- 2006: 1
- 2007: 1
- 2010: 2
- 2011: 1
- 2013: 3

## Most-cited predicates
- K041681: Atricure Dissector (2004), cited by 3
- K961122: Stryker Knifelight (1996), cited by 2
- K071180: Scintillant Surgical Light, Model 2644-01-0001 (2007), cited by 1
- K013242: Amsco Harmony Surgical Lighting and Media System (2001), cited by 1
- K003423: ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055 (2001), cited by 1
- K010724: Sola 700,Sola 500, Sola 300 (2001), cited by 1
- K111020: Atricure Dissector (2011), cited by 1
- K882613: Alm Surgical Lamps (1988), cited by 1

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