# K031530: BD Phoenix Automated Microbiology System-Nitrofurantoin-8-512 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 10, 2003 after 56 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: 1 generation back to K020322 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 3.
- 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.

## 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

## Most influential descendants
- K060447: BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML, Trimethoprim-Sulfamethoxazole (GN) (2006), 0 descendants of its own

## Indications for use
The BD Phoenixm 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-Enterob~!cten'aceae 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 nitrofurantoin at concentrations of 8-5 12 p g / d to Gram-negative ID/AST or AST only Phoenix panels. Nitrohrantoin has been shown to be active iit 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 APainst: Escherichia coli Active In Vitro Against: Citrobacter amalonaticus Citrobacter koseri (diversus) Citrobacterfreundii Klebsiella oxytoca Klebsiella pneumoniae (ozaenae)

Source page: https://510kreport.com/device/K031530
Methodology: https://510kreport.com/methodology