# K954924: Bactec Peds Plus Cluture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Diagnostic Instrument Systems
- Decided: Feb 8, 1996 after 105 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BACTEC NR6A Culture Vials: named in the summary without a submission number

## Indications for use
A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.

Source page: https://510kreport.com/device/K954924
Methodology: https://510kreport.com/methodology