# K123266: BD Phoenix Automated Microiology System- Ertapenem 0.0625-8 UG/ML-GN

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 26, 2013 after 250 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
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 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

## 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, Enterococcus and Streptococcus. Ertapenem 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 antimicrobial agent. Active In Vitro and in Clinical Infections Against: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Active In Vitro Citrobacter freundii Morganella morganii Citrobacter koseri Proteus vulgaris Enterobacter cloacae Providencia rettgeri Klebsiella oxytoca (excluding ESBL producing isolates) Providencia stuartii Serratia marcescens

Source page: https://510kreport.com/device/K123266
Methodology: https://510kreport.com/methodology