510(k) · Cleared
ClearedBD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Mar 15, 2024 as substantially equivalent to K060217 (Becton, Dickinson & CO, 2006) after an 88-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Mar 15, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020322 (2002). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 2 generations backK031306 BD Phoenix Automated Microbiology System - Moxifloxacin Gram PositiveBecton, Dickinson & CO · 2003
- 1 generation backK060217 BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and…Becton, Dickinson & CO · 2006
- This deviceK233986 BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin…Becton, Dickinson and Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −2 | K031306 | BD Phoenix Automated Microbiology System - Moxifloxacin Gram Positive | Becton, Dickinson & CO | 2003 | — |
| −1 | K060217 | BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and… | Becton, Dickinson & CO | 2006 | — |
| 0 (this device) | 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 |
| 2005 | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060217 | BD Phoenix Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25 -…Summary page 8…es(s): BD Phoenix™ Automated Microbiology System – Moxifloxacin-0.125-8 and Ciprofloxacin- 0.25-4 µg/mL B Predicate 510(k) Numbers(s): K060217 C Comparison with Predicate(s): CONFIDENTIAL AND PROPRIETARY… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2024, this device’s year, is highlighted.
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 Phoenix™ 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…
Read the full statement (160 words)
The BD Phoenix™ 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 the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 µg/mL. 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:
Citrobacter koseri Citrobacter freundii
Enterobacter cloacae Escherichia coli
Klebsiella pneumoniae Morganella morganii
Proteus mirabilis Proteus vulgaris,
Providencia rettgeri Providencia stuartii
Pseudomonas aeruginosa Salmonella typhi
Serratia marscescens Shigella boydii
Shigella dysenteriae Shigella flexneri
Shigella sonnei
Active In Vitro but clinical significance is unknown
Edwardsiella tarda Klebsiella aerogenes (formerly Enterobacter aerogenes)
Klebsiella oxytoca Salmonella enteritidis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233986 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233986: BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233986
Report an extraction error
Are you the manufacturer?
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