# MDB: System, Blood Culturing

- Device class: 1; regulation: 21 CFR 866.2560; FDA's rule: 510(k) required
- FDA decisions: 68
- 510(k) review time 2021–2025: median 211 days (middle half 211–212)
- Recalls: 72 (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)
- 2008: 1
- 2012: 2
- 2013: 4
- 2014: 1
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 2
- 2023: 2
- 2026: 1

## Most-cited predicates
- K915796: Bactec 9240 System (1992), cited by 2
- K921133: Bactec Plus Aerobic/F and Anaerobic/F Media (1992), cited by 2
- K903505: Bact/Alert (TM) (1991), cited by 2
- K954927: Bactec Peds Plus/F Culture Vials (1996), cited by 2
- K954925: Bactec Lytic/10 Anaerobic/F Culture Vials (1996), cited by 2
- K992432: Bact/Alert FN (1999), cited by 1
- K992401: Bact/Alert PF (1999), cited by 1
- K993576: Bact/Alert MP Process Bottle (1999), cited by 1
- K970512: Bactec Myco/F Lytic Culture Vials (1998), cited by 1
- K993421: Bact/Alert SN (1999), cited by 1

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