# K123903: BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 13, 2013 after 145 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 K954925 (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)
- K954925: Bactec Lytic/10 Anaerobic/F Culture Vials, Becton Dickinson Diagnostic Instrument Systems (1996) Summary page 1.

## Indications for use
BD BACTECTM Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with GO 2) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

Source page: https://510kreport.com/device/K123903
Methodology: https://510kreport.com/methodology