# HQY: Sunglasses (Non-Prescription Including Photosensitive)

- Device class: 1; regulation: 21 CFR 886.5850; FDA's rule: 510(k) exempt
- FDA decisions: 646
- 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)
- 1989: 8
- 1990: 60
- 1991: 22
- 1992: 23
- 1993: 66
- 1994: 211
- 1995: 90
- 1996: 63
- 1997: 51
- 1998: 5

## Most-cited predicates
- K900382: Blublocker Sunglasses (1990), cited by 1

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