# OUJ: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

- Device class: 2; regulation: 21 CFR 892.1570; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 146 days (middle half 133–159)
- 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)
- 2011: 1
- 2018: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K173865: trophon2 (2018), cited by 2
- K103059: Trophon (2011), cited by 1

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