# K063573: BD Phoenix  Automated Microbiology System-Ceftazidime (GN) 0.5-64 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 11, 2007 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: 3 generations back to K020322 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
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.
- K033560: BD Phoenix Automated Microbiology System - Ceftazidime 0.5-64 UG/ML-Gram-Negative ID/Ast or Ast Only Phoenix Panels, Becton, Dickinson & CO (2004) Summary page 1.
- K041384: BD Phoenix Automated Microbiology System - Ceftazidime - 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 Slaphylococcus, Enterococcus and Streplococcus. This premarket notification is for ceftazidime at concentrations of 0.5-64 gtg/mL to Grain-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Citrobacterfi-eundii and Stenotrophomonasmaltophilia. Ceftazidime 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: Citrobacterspp., including Citrobacterfreundii and Citrobacter koseri (formerly C. diversus) Enterobacterspp., including Enterobactercloacae and Enterobacteraerogenes Escherichia coli Klebsiella spp., including Klebsiellapneumnoniae Proteus mirabilis Proteus vulgaris Pseudaomonasspp., including Pseudomonasaeruginosa Serratiaspp. Active In Vitro: A4cinetobacter spp. Morganella morganii Providencia spp., including Providencia rettgeri Salmonella spp. Shigella spp.

Source page: https://510kreport.com/device/K063573
Methodology: https://510kreport.com/methodology