510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16 UG/ML, Ampicillin-Sulbactam (GN) 0.
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 Jul 3, 2006 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 3 other predicates after a 52-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K020322 (2002). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 1 generation backK031912 BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante…Becton, Dickinson & CO · 2003
- This deviceK061327 BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate…Becton, Dickinson & CO · 2006
- Descendant · cites it directly · 0 of its ownK071623 BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN)…Becton, Dickinson & CO · 2007
- Descendant · cites it directly · 0 of its ownK062680 BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128…Becton, Dickinson & CO · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −1 | K031912 | BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16… | Becton, Dickinson & CO | 2003 | — |
| 0 (this device) | K061327 | BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN)… | Becton, Dickinson & CO | 2006 | — |
| +1 | K071623 | BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN)… | Becton, Dickinson & CO | 2007 | — |
| +1 | K062680 | BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 UG/ML | Becton, Dickinson & CO | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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? (5)
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 |
|---|---|---|---|
| * | 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), Amoxicillin-clavulanate (K031912,… | 2002 |
| * | K031912 | BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 UG/MLSummary page 1…Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Amoxicillin-clavulanate (K031912, July 21, 2003), Ampicillin-sulbactam (K(043389,… | 2003 |
| * | K043389 | BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/MLSummary page 3…N50510 and BD Phoenix TM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Amoxicillin-clavulanate (K031912, July 21, 2003), Ampicillin-sulbactam (K043389, January 21, 2005), and Ticarcillin (K031984, August 27, 2003) BD Diagnostic Systems Becton, Dickinson and Company… | 2005 |
| * | K031984 | BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/MLSummary page 2…ides data for additional organism groups with Amoxicillin-clavulanate (0.5/0.25 - 32/16 gg/mL, Ampicillin-sulbactam (0.5/0.25-32/16 gg/mL), and Ticarcillin- 1-128 4g/mL (K031984, August 27, 2003) and the BD Phoenix TM Automated Microbiology System. SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING: The BD Phoen… | 2003 |
| * | — | VITEK® System (PMA No. N505 10) Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K071623 (Becton, Dickinson & CO, 2007) has gone furthest, with 0 descendants of its own.
- 102 other devices also cite its predicate K020321.
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-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This…
Read the full statement (239 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-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.
This premarket notification is for additional organism groups and Amoxicillin-clavulanate (0.5/0.25 - 32/16 Vg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 pg/mL), and Ticarcillin (1-128 ug/mL), on the BD Phoenix Automated Microbiology System.
Amoxicillin-clavulanate 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: Enterobacterspecies Escherichiacol/i Kiebsiella species
Active In Vitro Against: Proteus mirabilis
Ampicillin-sulbactam 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: Beta-lactamase producing strains of. Escherichia co/i Klethicl/u spp. (incholing K. pemunoniae)
Active In VitroAgainst: Eselhcrichic co/i (Bcta-lactainase and non-beta-htctaamasc piodueing) KNchsiclhi species (all known strains are beta-lactamasc producing , .torgruanella norgimii Providenc[e] W sirl)ii
Ticarcillin 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 A2ainst: Pseudonionasaeruginosa (and other species) Escherichia coli Proteus mirabilis Morganella morganil Providencia rettgeri Enterobacterspecies Salmonella species
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061327: BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16 UG/ML, Ampicillin-Sulbactam (GN) 0..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061327
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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