# K113558: BD BACTEC Plus Aerobic/F Culture Vials (plastic)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 16, 2012 after 106 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 1 (0 Class I)
- 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
- K222591: BD BACTEC™ Plus Aerobic/F Culture Vials (2023), 0 descendants of its own

## Recalls of this device
- Sep 12, 2023 · Class II · Z-0110-2024: Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

## Indications for use
The BD BACTEC Plus Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

Source page: https://510kreport.com/device/K113558
Methodology: https://510kreport.com/methodology