510(k) · Cleared
Recalled · Class II · 2026BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Sep 21, 2018 as substantially equivalent to K033458 (Becton, Dickinson & CO, 2004) after an 88-day review. Its family tree reaches back 2 generations to 2002. It has been recalled 2 times.
- Decided
- Sep 21, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- LON
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020322 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 1 generation backK033458 BD Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO · 2004 · Recalled
- This deviceK181665 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company · 2018
View 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 | K033458 | BD Phoenix Automated Microbiology System - Confirmatory Esbl Test | Becton, Dickinson & CO | 2004 | 1 |
| 0 (this device) | K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | Becton, Dickinson and Company | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K033458 | BD Phoenix Automated Microbiology System - Confirmatory Esbl TestSummary page 5…usceptible, intermediate, resistant or not susceptible. DEVICE COMPARISON: The BD Phoenix CPO detect test and the predicate device (BD Phoenix™ Confirmatory ESBL Test, K033458, May 28, 2004) have the following similarities: • Both tests are included on BD Phoenix™ GN panels • Both use isolated colo… | 2004 |
| * | — | BD Phoenix™ Automated Microbiology System – GN Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2026 | Class II | Z-0140-2027 | Under Investigation by firm | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| Aug 13, 2026 | Class II | Z-0139-2027 | Under Investigation by firm | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2018, this device’s year, is highlighted.
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 the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae. BD Phoenix CPO detect is a qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically…
Read the full statement (128 words)
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.
BD Phoenix CPO detect is a qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii on Gram-negative ID/AST or AST only Phoenix panels. The test also provides the Ambler classification (Class A, Class B and Class D) of the carbapenemase produced. One of three test configurations are available per panel for carbapenemase detection with/without Ambler classification for the target organism groups. BD Phoenix CPO detect does not report multiple classes of carbapenemases from a single isolate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181665: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181665
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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