# K041384: BD Phoenix Automated Microbiology System - Ceftazidime - Gram Negative

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 3, 2004 after 70 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.
1 later device descends 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.
- 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.

## Cited in the summary but kept off the family tree
- P505100: 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
- K063573: BD Phoenix  Automated Microbiology System-Ceftazidime (GN) 0.5-64 UG/ML (2007), 0 descendants of its own

## 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 and Enterococcus. This premarket notification is for the addition of the antimicrobial agent ceftazidime at concentrations of 0.5-64 pg/mL to gram-negative ID/AST or AST only Phoenix panels. 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: Citrobacter spp., excluding Citrobacter freundii Enterobacter spp., including Enterobacter cloacae, and Enterobacter aerogenes Escherichia coli Klebsiella spp., including Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp.

Source page: https://510kreport.com/device/K041384
Methodology: https://510kreport.com/methodology