# K222591: BD BACTEC™ Plus Aerobic/F Culture Vials

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 24, 2023 after 210 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921133 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113558: BD BACTEC Plus Aerobic/F Culture Vials (plastic), Becton, Dickinson and Company (2012) Summary page 6.

## Indications for use
BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC™ fluorescent series instruments. Additional information The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.

Source page: https://510kreport.com/device/K222591
Methodology: https://510kreport.com/methodology