# QLY: Ophthalmic Syringe

- Device class: 2; regulation: 21 CFR 880.5860; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 176 days (middle half 118–197)
- 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)
- 2020: 1
- 2023: 1
- 2024: 1
- 2025: 4

## Most-cited predicates
- K200242: StaClear Syringe (2020), cited by 4
- K243936: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (2025), cited by 1

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