# LYX: Media, Corneal Storage

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 135 days (middle half 123–156)
- 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)
- 1990: 1
- 1992: 3
- 1996: 1
- 2003: 1
- 2007: 2
- 2015: 1
- 2016: 1
- 2021: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K924165: Optisol-GS Corneal Storage Media (1992), cited by 5
- K032422: Eusol-C (2003), cited by 1
- K921729: Optisol Corneal Storage Media Container/Modified (1992), cited by 1

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