# OWD: Somatic Gene Mutation Detection System

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 19
- Recalls: 6 (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)
- 2017: 17
- 2018: 36
- 2019: 16
- 2020: 15
- 2021: 13
- 2022: 12
- 2023: 24
- 2024: 9
- 2025: 8
- 2026: 9

## Most-cited predicates

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