# K020321: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 23, 2002 after 128 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
No predicates in its family tree.
118 later devices descend from it; 103 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P050510: VITEK® System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative (2006), 11 descendants of its own
- K023301: BD Phoenix Automated Microbiology System (2002), 10 descendants of its own
- K071026: BD Geneohm Staphsr Assay (2007), 9 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K043389: BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML (2005), 3 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™ 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 addition of the antimicrobial Gatifloxacin at concentrations of 0.25-8 pg to Gram negative and Gram positive ID/AST or AST only Phoenix panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infections Against: Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis Active In Vitro Against: Aerobic Gram-positive microorganisms Staphylococcus saprophyticus Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris Results for Enterobacteriaceae tested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.

Source page: https://510kreport.com/device/K020321
Methodology: https://510kreport.com/methodology