# K161306: BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson
- Decided: Aug 8, 2016 after 90 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 K915796 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915796: Bactec 9240 System, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 4.

## Indications for use
BD BACTEC™ Standard Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

Source page: https://510kreport.com/device/K161306
Methodology: https://510kreport.com/methodology