# OCU: Endoscopic Storage Cover

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 161 days (middle half 161–161)
- 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)
- 1994: 1
- 1995: 1
- 2003: 1
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K951104: Endoboot (1995), cited by 2
- K191011: Scope ProTech (2019), cited by 1

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