# K062207: BD Phoenix Automated Microbiology System - Cefuroxime (GN) 1-64 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Sep 13, 2006 after 43 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: 2 generations back to K020322 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K033362: BD Phoenix Automated Microbiology System- Cefuroxime Gram Negative, Becton, Dickinson & CO (2004) Summary page 1.

## 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 PhoenixTM 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. This premarket notification is for cefuroxime with additional organism groups and the removal of the limitation for Klebsiella pneumoniae from the original premarket notification (K033362, April 13, 2004). Cefuroxime 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; Enterobacter species; Klebsiella species. Active In Vitro Against: Citrobacter species; Enterobacter species; Escherichia coli; Klebsiella species (including K. pneumoniae); Morganella morganii; Proteus mirabilis; Salmonella species; Shigella species.

Source page: https://510kreport.com/device/K062207
Methodology: https://510kreport.com/methodology