# MVD: System, Test, Her-2/Neu, Nucleic Acid Or Serum

- Device class: 2; regulation: 21 CFR 864.1890; FDA's rule: 510(k) required
- FDA decisions: 3
- 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: 7
- 2013: 5
- 2014: 1
- 2015: 1
- 2016: 4
- 2017: 2
- 2018: 3
- 2019: 1
- 2020: 1
- 2022: 1

## Most-cited predicates

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