# QBN: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

- Device class: 2; regulation: 21 CFR 866.3378; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 156 days (middle half 123–188)
- 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)
- 2018: 2
- 2022: 1
- 2025: 1

## Most-cited predicates
- DEN170081: MALDI Biotyper CA System (2018), cited by 3
- K181412: Vitek MS (2018), cited by 2

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