# HKN: Refractor, Manual, Non-Powered, Including Phoropter

- Device class: 1; regulation: 21 CFR 886.1770; FDA's rule: 510(k) exempt
- FDA decisions: 3
- 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)
- 1979: 1
- 1987: 1
- 1994: 1

## Most-cited predicates
- K936205: Comprehensive Phoropter, MDR-680 (1994), cited by 1

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