510(k) · Cleared
ClearedBD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML, Trimethoprim-Sulfamethoxazole (GN)
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 Apr 26, 2006 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 3 other predicates after a 64-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Apr 26, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K020322 (2002). 6 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 backK030579 BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 UG/MLBecton, Dickinson & CO · 2003
- This deviceK060447 BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512…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 | K030579 | BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 UG/ML | Becton, Dickinson & CO | 2003 | — |
| 0 (this device) | K060447 | BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML… | Becton, Dickinson & CO | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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 | N50510 | FDA’s N50510 is Vitek Systems General Susceptibility Card Number could not be read Summary page 1…Antimicrobial Susceptibility Device, 21 CFR 866.1645 PREDICATE DEVICES: VITEK® System (PMA No. N50510) and BD PhoenixTM Automated Microbiology System with Gatifloxacin… | 1978 |
| * | K020321 | BD Phoenix Automated Microbiology SystemSummary page 1…No. N50510) and BD PhoenixTM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Nitrofurantoin (K031530, July 10, 2003), Trimethoprim-sulfamethoxaz… | 2002 |
| * | K031530 | BD Phoenix Automated Microbiology System-Nitrofurantoin-8-512 UG/MLSummary page 1…Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Nitrofurantoin (K031530, July 10, 2003), Trimethoprim-sulfamethoxazole (K033907, April 9,… | 2003 |
| * | K033907 | BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5 -…Summary page 1…(K020321, May 23, 2002), Nitrofurantoin (K031530, July 10, 2003), Trimethoprim-sulfamethoxazole (K033907, April 9, 2004) and Nalidixic Acid (K030579, March 21, 2003). INTENDED USE:… | 2004 |
| * | K030579 | BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 UG/MLSummary page 1…2003), Trimethoprim-sulfamethoxazole (K033907, April 9, 2004) and Nalidixic Acid (K030579, March 21, 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 3.1 years on median.
- 1 of the 6 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 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 Enterobacteriaceaeand Non-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This…
Read the full statement (226 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 Enterobacteriaceaeand Non-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.
This premarket notification is for additional organism groups and BD PhoenixTM Automated. Microbiology System with Nitrofurantoin (8-512 gg/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 fig/ mL) and Nalidixic Acid (2-32gg/mL) on Gram-negative lD/AST or AST only Phoenix panels.
Nitrofurantoin 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:
Escherichiacoli
Active In Vitro Against:
Citrobacteramalonaticus
Citrobacterkoseri (diversus)
Citrobacterfreundii
Klebsiella oxytoca
Klebsiellapneumoniae (ozaenae)
Trimethoprim-sulfamethoxazole 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:
Escherichiacoli Proteus mirabilis
Klebsiella species Proteusvulgaris
Enterobacter species Shigellaflexneri
Morganella morganii Shigella sonnei
Nalidixic Acid 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:
Enterobacter species Morganella morganii Proteus vulgaris
Escherichiacoli Proteusmirabilis Providenciarettgeri
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060447: BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML, Trimethoprim-Sulfamethoxazole (GN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060447
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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