# EYN: Tray, Irrigation, Sterile

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1977: 1
- 1978: 1
- 1979: 4
- 1980: 1
- 1990: 3
- 1993: 4
- 1995: 1

## Most-cited predicates

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