# K151866: BD BACTEC Peds Plus/F Culture Vials (plastic)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 25, 2016 after 231 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 K954927 (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)
- K954927: Bactec Peds Plus/F Culture Vials, Becton Dickinson Diagnostic Instrument Systems (1996) Summary page 4.

## Indications for use
BD BACTEC Peds Plus™/F Culture Vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 5 mL in volume.

Source page: https://510kreport.com/device/K151866
Methodology: https://510kreport.com/methodology