# OVY: Liquid Chemical Processing System

- Device class: 2; regulation: 21 CFR 880.6887; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 59 days (middle half 44–73)
- 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)
- 2012: 1
- 2018: 1
- 2023: 2

## Most-cited predicates
- DEN110002: System 1E Process Biological Monitoring Kit (2012), cited by 2
- K231746: VERIFY Spore Test Strip for S40 Sterilant Concentrate (2023), cited by 1
- K180553: VERIFY Spore Test Strip for S40 Sterilant (2018), cited by 1

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