510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative
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 May 25, 2006 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 2 other predicates after a 105-day review. Its family tree reaches back 1 generation to 2002. 11 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 105 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. 11 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- This deviceK060324 BD Phoenix Automated Microbiology System for Use with the…Becton, Dickinson & CO · 2006
- Descendant · cites it directly · 1 of its ownK061867 BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/MLBecton, Dickinson & CO · 2006
- Descendant · cites it directly · 0 of its ownK082852 BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128…Becton, Dickinson & CO · 2009
- Descendant · cites it directly · 0 of its ownK082913 BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16…Becton, Dickinson & CO · 2008
- Descendant · cites it directly · 0 of its ownK082538 BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide…Becton, Dickinson & CO · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK073589 BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16…Becton, Dickinson & CO · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K061867BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/MLBecton, Dickinson & CO · 2006 · cites it directly1descendant
- K082852BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/MLBecton, Dickinson & CO · 2009 · cites it directly0descendants
- K082913BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/MLBecton, Dickinson & CO · 2008 · cites it directly0descendants
- K082538BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance TestBecton, Dickinson & CO · 2008 · cites it directly0descendants
- K073589BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML) Steptococcus…Becton, Dickinson & CO · 2008 · cites it directly0descendants
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) | K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent… | Becton, Dickinson & CO | 2006 | — |
| +1 | K061867 | BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/ML | Becton, Dickinson & CO | 2006 | — |
| +1 | K082852 | BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/ML | Becton, Dickinson & CO | 2009 | — |
| +1 | K082913 | BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/ML | Becton, Dickinson & CO | 2008 | — |
| +1 | K082538 | BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide… | Becton, Dickinson & CO | 2008 | 1 |
| +1 | K073589 | BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML)… | Becton, Dickinson & CO | 2008 | — |
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 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 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 | 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 | |
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 1…DEVICES: VITEK® System (PMA No. N50510) 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…M 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…xacin (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? (11)
See all 1110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061867 | BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/ML | 2006 | 1 |
| K082852 | BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/ML | 2009 | 0 |
| K082913 | BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/ML | 2008 | 0 |
| K082538 | BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test | 2008 | 0 |
| K073589 | BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML) Steptococcus… | 2008 | 0 |
| K070809 | BD Phoenix Automated Microbiology System-Minocycline (GP) 1-32 UG/ML | 2007 | 0 |
| K063486 | BD Phoenix Automated Microbiology System Minocycline (1-32 UG/ML) Gram Negative ID/Ast… | 2007 | 0 |
| K062945 | BD Phoenix Automated Microbiology System - Ertapenem (GN) 0.25-32 UG/ML | 2006 | 0 |
| K061869 | BD Phoenix Automated Microbiology System-Piperacillin-Tazobactam (GP) 1/4-128/4 UG/ML | 2006 | 0 |
| K061673 | BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GP) 0.25/0.12 -32/16… | 2006 | 0 |
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 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 (154 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 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 additional Gram-negative organism groups and Gatifloxacin (0.25-8 itg/mL) on the BD Phoenix Automated Microbiology System. Gatifloxacin 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: Active In Vitro Against:
Aerobic Gram-negative microorganisms Aerobic Gram-negative microorganisms
Escherdchin coi Acinetobacter Iwoff1i
Klebsiella pneumoniae Citrobecter kosed
Proteus mirabilis Citrobacterfreundii
Enterobacter aerogenes
Enterobacter cloacae
Klebsiella oxytoca
Morganellsmorganii
Proteus vulgaris
Results for Enterobacteriaceaetested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060324
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