# K120994: BD BACTEC Plus PRIME Aerobic/F Culture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 7, 2012 after 127 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)
- K083572: BD BACTEC Plus Aerobic/F Culture Vials, Becton, Dickinson & CO (2008) Summary page 1.

## Indications for use
The BD BACTEC Plus PRIME Aerobic/F blood culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.

Source page: https://510kreport.com/device/K120994
Methodology: https://510kreport.com/methodology