# K040099: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 19, 2004 after 59 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020322 (2002). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020321: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K020323: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K020322: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.

## Most influential descendants
- K070346: Dade Behring Labpro Alert Software System (2007), 1 descendant of its own
- K201405: LabPro Data Management System (2020), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0239-2026: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is 
- Oct 31, 2024 · Class II · Z-0592-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Aug 1, 2024 · Class II · Z-3246-2024: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections
- Aug 1, 2024 · Class II · Z-3247-2024: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections

## Indications for use
The BD Phoenix TM Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus. This premarket notification is for the Modifications to Phoenix System Software and for the BDXpert System resident on the EpiCenter System.

Source page: https://510kreport.com/device/K040099
Methodology: https://510kreport.com/methodology