# K161810: BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson
- Decided: Feb 9, 2017 after 223 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 K954921 (1996). 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)
- K954921: Bactec Standard/10 Aerobic/F Culture Vials, Becton Dickinson Diagnostic Instrument Systems (1996) Summary page 4.

## Indications for use
BD BACTEC™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood.

Source page: https://510kreport.com/device/K161810
Methodology: https://510kreport.com/methodology