510(k) · Cleared
Recalled · 2011BD Phoenix Automated Microbiology System - Confirmatory Esbl Test
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 28, 2004 as substantially equivalent to K031545 (Trek Diagnostic Systems, Inc., 2003) and 3 other predicates after a 211-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- May 28, 2004
- Review
- 211 days
- Class
- Class II
- Product code
- LON
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K020322 (2002). 4 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 deviceK033458 BD Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO · 2004
- Descendant · cites it directly · 0 of its ownK181665 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company · 2018 · 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) | K033458 | BD Phoenix Automated Microbiology System - Confirmatory Esbl Test | Becton, Dickinson & CO | 2004 | — |
| +1 | K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | Becton, Dickinson and Company | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K031545 | Sensititre 18-24 Hour Susceptibility PlateSummary page 1…Antimicrobial Susceptibility Device, 21 CFR 866.1645 PREDICATE DEVICES: Sensititre® ESBL confirmatory test plate (K03 1545) and BD PhoeniXTm Automated Microbiology System with… | 2003 |
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 1…st plate (K03 1545) and BD PhoeniXTm Automated Microbiology System with Gatifloxacin (K02032 1, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322,… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…Automated Microbiology System with Gatifloxacin (K02032 1, 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…Gatifloxacin (K02032 1, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE: The BD Phoenix Tm Automate… | 2002 |
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 |
|---|---|---|---|
| K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2011 | Not classified | Z-1847-2011 | Mixed-up of materials/components | In vitro diagnostic test kit is defective and may cause false positive or false negative results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K181665 (Becton, Dickinson and Company, 2018) has gone furthest, with 0 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 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 and Enterococcus. This premarket notification…
Read the full statement (102 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 and Enterococcus.
This premarket notification is for the addition of the confirmatory ESBL Test to Gram-negative ID/AST or AST only Phoenix panels. The Phoenix confirmatory ESBL Test is a confirmatory test for the detection of the organisms that produce extended spectrum P3-lacta ..es (ESBL) in Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033458: BD Phoenix Automated Microbiology System - Confirmatory Esbl Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033458
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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