# K083572: BD BACTEC Plus Aerobic/F Culture Vials

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 24, 2008 after 21 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: 1 generation back to K921133 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921133: Bactec Plus Aerobic/F and Anaerobic/F Media, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.

## Most influential descendants
- K120994: BD BACTEC Plus PRIME Aerobic/F Culture Vials (2012), 0 descendants of its own

## Indications for use
BD BACTEC Plus 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/K083572
Methodology: https://510kreport.com/methodology