510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa.
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 Mar 29, 2006 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 3 other predicates after a 33-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Mar 29, 2006
- Review
- 33 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K020322 (2002). 4 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 backK030677 BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveBecton, Dickinson & CO · 2003 · Recalled
- This deviceK060493 BD Phoenix Automated Microbiology System - Vancomycin-GP Detection…Becton, Dickinson & CO · 2006
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 | K030677 | BD Phoenix Automated Microbiology System-Vancomycin Gram Positive | Becton, Dickinson & CO | 2003 | 2 |
| 0 (this device) | K060493 | BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa. | Becton, Dickinson & CO | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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; 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 1…ICATE DEVICES: VITEKgSystem (PMA No. N505 10) and BD PhoenixT Automated Microbiology System with Gatifloxacin (K02032 1, May 23, 2002), Ofloxacin (K020323, April 14, 2002),… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…oenixT Automated Microbiology System with Gatifloxacin (K02032 1, May 23, 2002), Ofloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002), and Vancomycin… | 2002 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 1…h Gatifloxacin (K02032 1, May 23, 2002), Ofloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002), and Vancomycin (K(030677, April 1, 2003). INTENDED USE:… | 2002 |
| * | K030677 | BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveSummary page 3…(susceptible, intermediate, and resistant). Table 1 summarizes the performance for the isolates tested in this study and included in the 510(k) premarket notification (K030677, April 1, 2003) for vancomycin and Gram-positive organisms and the Phoenix System. Table 1: Performance of BD Phoenix S… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 of the 4 ancestors have a recall of any class.
- 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 PhoenixT'M 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…
Read the full statement (127 words)
The BD PhoenixT'M 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 to demonstrate the ability to detect vancomycin resistant Staphylococcus aureus (VRSA) with the antimicrobial agent vancomycin at concentrations of 0.5-32 pg/mL (K030677, April 1,2003) and Gram positive ID/AST or AST only Phoenix panels. Vancomycin 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 antinicrobic.
Active In Vitro and in Clinical Infections Against:
Staphylococcus species
Enterococcus species
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060493: BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060493
Report an extraction error
Are you the manufacturer?
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