# MKT: Hepatitis Viral B Dna Detection

- Device class: 2; regulation: 21 CFR 866.3174; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 7 (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)
- 2016: 16
- 2017: 13
- 2018: 29
- 2019: 28
- 2020: 14
- 2021: 9
- 2022: 9
- 2023: 16
- 2024: 18
- 2025: 10

## Most-cited predicates

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