510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System -Ciprofloxacin GN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Oct 3, 2005 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Oct 3, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K020322 (2002). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- This deviceK052269 BD Phoenix Automated Microbiology System -Ciprofloxacin GNBecton, Dickinson & CO · 2005
- Descendant · cites it directly · 1 of its ownK060217 BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and…Becton, Dickinson & CO · 2006
- Descendant · 2 generations on · 0 of its ownK233986 BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin…Becton, Dickinson and Company · 2024
Most influential descendants
Showing 2 of 2 · See all- K060217BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 -…Becton, Dickinson & CO · 2006 · cites it directly1descendant
- K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)Becton, Dickinson and Company · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| 0 (this device) | K052269 | BD Phoenix Automated Microbiology System -Ciprofloxacin GN | Becton, Dickinson & CO | 2005 | — |
| +1 | K060217 | BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and… | Becton, Dickinson & CO | 2006 | — |
| +2 | K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | Becton, Dickinson and Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P050010 | FDA’s P050010 is Prodisc -L Total Disc Replacement Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 1…VITEK® System (PMA No. N505 10) and BD PhoenixTM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE:… | 2002 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 1…(K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE: The BD PhoenixTM Automated Microbiology System is… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060217 | BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 -… | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
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…
Read the full statement (193 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052269: BD Phoenix Automated Microbiology System -Ciprofloxacin GN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052269
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026