# OJU: Skin Prep Tray

- Device class: 1; regulation: 21 CFR 878.4800
- FDA decisions: 1
- Recalls: 7 (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)
- 1978: 1

## Most-cited predicates

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