# K260213: BD BACTEC FXI Culture System

- Pathway: 510(k) (Traditional)
- Applicant: BD Diagnostic Systems
- Decided: May 28, 2026 after 125 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 K962210 (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)
- K962210: Bactec 9050 System, Becton Dickinson Diagnostic Instrument Systems (1996) Summary page 9.

## Indications for use
The automated BD BACTEC FXI Culture System is designed for the qualitative detection of bacteria and fungi in blood. Samples are collected from patients and injected directly into BD BACTEC culture vials, which are placed into the instrument for incubation and testing.

Source page: https://510kreport.com/device/K260213
Methodology: https://510kreport.com/methodology