# K073433: BD Phoenix Automated Microbiology System-Piperacillin (GN) -128 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 14, 2008 after 39 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)
- K041572: BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 UG/ML, Becton, Dickinson and 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 Piperacillin at concentrations of 2-128 }zg/mL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus mirabilis, Providencia species and Stenotrophomonas mcaltophilia. Piperacillin 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: Acinetobacter species Klebsiella species Providencia rettgeri Enterobacter species Morganella morganii Pseudoironas aeruginosa Escherichia coli Proteus mirabilis Serratia species Active In Vitro Against: Burkholderia cepacia Citrobacter fi'eundii Stenotrophomonas maltophi/ia Citrobacter diversus Pseudomonas fluorescens Yersinia enterocolitica

Source page: https://510kreport.com/device/K073433
Methodology: https://510kreport.com/methodology