# QYM: Ophthalmic Needle

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 148 days (middle half 124–173)
- 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)
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K230951: Terumo Injection Filter Needle (NF-3013RBKE05M) (2023), cited by 1

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