510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System
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 Apr 4, 2002 after a 79-day review. The FDA summary names its predicate without a number. 118 later devices descend from it.
- Decided
- Apr 4, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 91 citing it directly.
- This deviceK020323 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- Descendant · cites it directly · 11 of its ownK060324 BD Phoenix Automated Microbiology System for Use with the…Becton, Dickinson & CO · 2006
- Descendant · cites it directly · 10 of its ownK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- Descendant · 2 generations on · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · 2 generations on · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · cites it directly · 3 of its ownK043389 BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN)…Becton, Dickinson & CO · 2005
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…Becton, Dickinson & CO · 2006 · cites it directly11descendants
- K023301BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · cites it directly10descendants
- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · 2 generations on9descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · 2 generations on3descendants
- K043389BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/MLBecton, Dickinson & CO · 2005 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020323 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| +1 | K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent… | Becton, Dickinson & CO | 2006 | — |
| +1 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| +2 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +2 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +1 | K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN)… | Becton, Dickinson & CO | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 9 | 0 |
| 2003 | 24 | 0 |
| 2004 | 15 | 0 |
| 2005 | 23 | 0 |
| 2006 | 21 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | — | VITEK® System Named without a submission number |
What descends from it? (118)
See all 11891 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060324 | BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent… | 2006 | 11 |
| K023301 | BD Phoenix Automated Microbiology System | 2002 | 10 |
| K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML | 2005 | 3 |
| K032675 | BD Phoenix Automated Microbiology System-Cefepime (GN) 0.5-65 UG/ML | 2004 | 3 |
| K032655 | BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 UG/ML | 2003 | 3 |
| K031984 | BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/ML | 2003 | 3 |
| K031912 | BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 UG/ML | 2003 | 3 |
| K052269 | BD Phoenix Automated Microbiology System -Ciprofloxacin GN | 2005 | 2 |
| K040099 | BD Phoenix Automated Microbiology System | 2004 | 2 |
| K033560 | BD Phoenix Automated Microbiology System - Ceftazidime 0.5-64 UG/ML-Gram-Negative ID/Ast… | 2004 | 2 |
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?
- Of its descendants, K060324 (Becton, Dickinson & CO, 2006) has gone furthest, with 11 descendants of its own.
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 Phoenix™ Automated Microbiology System is intended for in vifro 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, Non-Enterobacteriaceae and most glucose nonfermenting gram-positive bacteria isolates from pure culture belonging for Staphylococcus and Enterococcus. This premarket…
Read the full statement (199 words)
The BD Phoenix™ Automated Microbiology System is intended for in vifro 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, Non-Enterobacteriaceae and most glucose nonfermenting gram-positive bacteria isolates from pure culture belonging for Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial Ofloxacin at concentrations of 0.25-8 g to Gram negative and Gram positive ID/AST or AST only Phoenix panels. Ofloxacin 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 antimicrobic.
Active In Vitro and in Clinical Infections Against: Active In Vitro Against:
Aerobic Gram-positive microorganisms Aerobic Gram-positive microorganisms
Staphylococcus aureus Staphylococcus epidermidis (excluding methicillin-resistant strains)
Staphylococcus haemolyticus
Aerobic Gram-negative microorganisms Staphylococcus saprophyticus
Citrobacter koseri (formerly Citrobacter diversus)
Enterobacter aerogenes Aerobic Gram-negative microorganisms
Escherichia coli Acinetobacter calcoaceticus
Klebsiella pneumoniae Aeromonas caviae
Proteus mirabilis Aeromonas hydrophila
Pseudomonas aeruginosa Citrobacter freundii
Enterobacter cloacae
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Serratia marcescens
Results for Enterobacteriaceae, Pseudomonas aeruginosa and other Non-Enterobacteriaceae tested with Ofloxacin should only be reported for isolates recovered from the urinary tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020323: BD Phoenix Automated Microbiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020323
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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