# HRH: Trephine, Manual, Ophthalmic

- Device class: 1; regulation: 21 CFR 886.4350; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1977: 1
- 1978: 1
- 1981: 1
- 1984: 1
- 1985: 1
- 1986: 3
- 1987: 2
- 1994: 1
- 2002: 1

## Most-cited predicates
- K864520: Barron Rotary Blade Trephine Using Hessburg-Barron (1987), cited by 3
- K843646: Steinway Micro-Kerato-Trephine (1985), cited by 1
- K861825: Corneal Transplant Trephine Disposable Blade (1986), cited by 1

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