510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate-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 Jan 14, 2004 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Jan 14, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K020322 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- This deviceK033557 BD Phoenix Automated Microbiology System -…Becton, Dickinson & CO · 2004
- Descendant · cites it directly · 0 of its ownK062687 BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate…Becton, Dickinson & CO · 2006
Most influential descendants
Showing 1 of 1 · See all- K062687BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (GN) 1/2 - 128/2UG/MLBecton, Dickinson & CO · 2006 · 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) | K033557 | BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate-Gram Negative | Becton, Dickinson & CO | 2004 | — |
| +1 | K062687 | BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (GN) 1/2 -… | Becton, Dickinson & CO | 2006 | — |
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 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 1…TE DEVICES: VITEK® System (PMA No. N505 10) and BD Phoenix TM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…enix TM 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…atifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE: The BD Phoenix TM Automated Microbiology System is… | 2002 |
| * | — | VITEK® System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062687 | BD Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (GN) 1/2 - 128/2UG/ML | 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 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 and Enterococcus. This premarket notification…
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 and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent ticarcillin/clavulanate at concentrations of 1/2 - 128/2 [ig/mL to gram-negative ID/AST or AST only Phoenix panels. Ticarcillin/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
(both [3-lactamase producing and non [3-lactamase producing):
Citrobacter species Escherichia coli
Enterobacter species Klebsiella species
Active In Vitro Against:
(both [3-lactamase producing and non P-lactamase producing):
Acinetobacter baumannii Morganella morganii Proteus vulgaris
Acinetobacter calcoaceticus Proteus mirabilis Providencia rettgeri
Acinetobacter haemolyticus Proteus penneri Providencia stuartii
Acinetobacter iwoffi
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033557: BD Phoenix Automated Microbiology System - Ticarcillin/Clavulanate-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/K033557
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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