510(k) · Cleared
Recalled · Class III · 2016BD 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 Nov 12, 2002 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 2 other predicates after a 40-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 12, 2002
- Review
- 40 days
- Class
- Class II
- Product code
- LON
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K020322 (2002). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- This deviceK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- Descendant · cites it directly · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · cites it directly · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK130894 Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I…Cepheid · 2013
- Descendant · 2 generations on · 1 of its ownK102342 Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · cites it directly9descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · cites it directly3descendants
- K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · 2 generations on2descendants
- K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid · 2013 · 2 generations on1descendant
- K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011 · 2 generations on1descendant
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) | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| +1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +1 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +2 | K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | Cepheid | 2010 | 1 |
| +2 | K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV… | Cepheid | 2013 | — |
| +2 | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | Microphage, Inc. | 2011 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P050510 | VITEK System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 3…quivalent to those used in the VITEK@system, which received approval by the FDA under PMA number N505 10 and BD PhoenixTMAutomated Microbiology System with Gatifloxacin (K020321, May 23,2002), Ofloxacin (K020323, April 14,2002), and Levofloxacin (K020322, March 27,2002). BD Diagnostic Systems Becton, D… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…M Automated Microbiology System with Gatifloxacin (KO2032 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…oxacin (KO2032 1, May 23,2002), Ofloxacin (K020323, April 14,2002), and Levofloxacin (K020322, March 27,2002). INTENDED USE: The BD PhoenixTMAutomated Microbiology System is… | 2002 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2016 | Class III | Z-0312-2017 | Process control | BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within… |
| Jun 1, 2016 | Class III | Z-0311-2017 | Process control | BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual… |
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 PhoenixTh' 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-Enrerobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Sraphylococcus and Enterococcus. This premarket…
Read the full statement (118 words)
The BD PhoenixTh' 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-Enrerobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Sraphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent Oxacillin at concentrations of 0.0625-4 pg/mL to Gram Positive ID/AST or AST only Phoenix panels. Oxacillin 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:
Aerobic Gram-positive microorganisms
Staphylococcus spp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023301: 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/K023301
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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