# K250344: BD Phoenix™ Automated Microbiology System

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 6, 2025 after 28 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- 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 K131331 (2013). 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)
- K131331: BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 UG/ML), Becton, Dickinson & CO (2013) Summary page 7.

## Indications for use
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.

Source page: https://510kreport.com/device/K250344
Methodology: https://510kreport.com/methodology