# K052269: BD Phoenix Automated Microbiology System -Ciprofloxacin GN

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 3, 2005 after 45 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.
2 later devices descend 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.

## Cited in the summary but kept off the family tree
- P050010: Prodisc -L Total Disc Replacement Device, Centinel Spine, LLC (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K060217: BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 - 4 UG/ML (2006), 1 descendant of its own
- K233986: BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (2024), 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 Enterobacteriaceaeand Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus. This premarket notification is for the removal of limitations for Enterobactercloacae and Serratia species from the original premarket notification [K023895, 1/8/2003] for the antimicrobial agent ciprofloxacin at concentrations of 0.25-4 gg/ml to Gram-negative ID/AST or AST only Phoenix panels. The concentration range has been reduced by one dilution from the range of 0.125-4gg/ml in the original 5 10(k). Ciprofloxacin 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: Aerobic Gram-negative microorganisms Citrobacterkoseri Proteus mirabilis Serratiamarcescens Citrobacterfreundii Proteus vulgaris Shigella boydii Enterobactercloacae Providenciarettgeri Shigella dysenteriae Escherichiacoli Providenciastuartii Shigellaflexneri Klebsiella pneumoniae Pseudomonas aeruginosa Shigella sonnei Morganella morganii Salmonella typhi Active In Vitro Against: Aerobic Gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Aeromonas hydrophila Salmonella enteritidis Edwardsiella tarda Yersinia enterocolitica Enterobacteraerogenes

Source page: https://510kreport.com/device/K052269
Methodology: https://510kreport.com/methodology