# FTF: Illuminator, Non-Remote

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1984: 3
- 2004: 1

## Most-cited predicates
- K840372: Flexible Illuminator 15 (1984), cited by 2
- K840373: Flexible Illuminator 10 (1984), cited by 1
- K840371: Flexible Illuminator 5 (1984), cited by 1
- K041621: Liteport LP100 Surgical Illuminator (2004), cited by 1

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