# OOX: Automated Occult Blood Analyzer

- Device class: 2; regulation: 21 CFR 864.6550; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 801 days (middle half 801–801)
- 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)
- 2004: 1
- 2010: 1
- 2014: 1
- 2017: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- K041408: Polymedco OC Auto Micro 80 Fob Test (2004), cited by 2
- K092330: OC-Sensor Diana Ifob Test (2010), cited by 1
- K132167: I-Chroma Ifob with I-Chroma Reader (2014), cited by 1

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