510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/ML
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 11, 2006 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 3 other predicates after a 70-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 11, 2006
- Review
- 70 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 backK031943 BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 UG/MLBecton, Dickinson & CO · 2003
- This deviceK060558 BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/MLBecton, 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 | K031943 | BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 UG/ML | Becton, Dickinson & CO | 2003 | — |
| 0 (this device) | K060558 | BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/ML | 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…DEVICES: VITEK® System (PMA No. N50510) and BD PhoenixTM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002),… | 2002 |
| * | K020323 | BD Phoenix Automated Microbiology SystemSummary page 1…xTM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002), Cephalothin… | 2002 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 1…atifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002), Cephalothin (K031943, August 6, 2003). INTENDED USE:… | 2002 |
| * | K031943 | BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 UG/MLSummary page 1…loxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002), Cephalothin (K031943, August 6, 2003). INTENDED USE: The BD PhoenixTM Automated Microbiology System is… | 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 2.8 years on median.
- 1 of the 4 ancestors has 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 PhoenixMT 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, Enterococcus, and Streptococcus. This…
Read the full statement (162 words)
The BD PhoenixMT 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, Enterococcus, and Streptococcus.
This premarket notification is for additional Gram-negative organism groups and Cephalothin (1-64 gg/mL) on the BD Phoenix Automated Microbiology System.
Cephalothin has been shown to be active in vitro against most strains of microorganisms listed below. Because the drug insert for cephalothin (CF) was unavailable, the organisms that were included are those organisms listed in other sources such as "The Sanford Guide to Antimicrobial Therapy" for 1st generation cephalosporins and/or those organisms listed in the drug inserts for those drugs for which cephalothin is considered the predictor of activity per the CLSI M100-S15, Table 2C.
Active In Vitro and in Clinical Infections Against:
Escherichia coli
Klebsiella pneumioniae
Proteus mirabilis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060558: BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060558
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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