# HQH: Eye, Artificial, Non-Custom

- Device class: 1; regulation: 21 CFR 886.3200; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1980: 1
- 1991: 1
- 1992: 1
- 1995: 3

## Most-cited predicates

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