# HKS: Prism, Gonioscopic

- Device class: 1; regulation: 21 CFR 886.1660; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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)
- 1983: 1
- 1986: 5
- 1989: 2
- 1994: 1
- 2014: 1

## Most-cited predicates
- K140368: Family of Disposable Lenses (2014), cited by 1

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