# FSP: Loupe, Diagnostic/Surgical

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 1 (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)
- 1986: 2
- 1989: 2

## Most-cited predicates

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