# HNN: Knife, Ophthalmic

- Device class: 1; regulation: 21 CFR 886.4350; FDA's rule: 510(k) exempt
- FDA decisions: 54
- Recalls: 113 (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)
- 1981: 3
- 1982: 3
- 1983: 4
- 1984: 5
- 1985: 11
- 1986: 13
- 1987: 4
- 1988: 3
- 1992: 1
- 2011: 1

## Most-cited predicates
- K863725: Cataract Diamond Knife (1986), cited by 2
- K853598: Ophthalmic Knife W/Removale Depth Guide (1985), cited by 1
- K822112: Ophthalmic Knife (1982), cited by 1

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