510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test

K082538510(k) TraditionalCleared Nov 20, 200879-day reviewClass II21 CFR 866.1645Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson & CO · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Nov 20, 2008 as substantially equivalent to K073653 (Trek Diagnostic Systems, Inc., 2008) and 4 other predicates after a 79-day review. Its family tree reaches back 2 generations to 2002. It has been recalled once.

Decided
Nov 20, 2008
Review
79 days
Class
Class II
Product code
LON
Recalls
1
Predicates
5

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.

Other ancestors, by year cleared 2008: 1 other ancestor2002: 2 other ancestorsK020322 · BD Phoenix Automated Microbiology System · Becton, Dickinson & CO · 2002K060324 · BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative · Becton, Dickinson & CO · 2006200020022004200620082010
Other ancestors, by generation 1 generation back: 3 other ancestors K060324 · BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative · Becton, Dickinson & CO · 2006K020322 · BD Phoenix Automated Microbiology System · Becton, Dickinson & CO · 20020
  1. Root · 2 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
  2. 1 generation backK060324 BD Phoenix Automated Microbiology System for Use with the…Becton, Dickinson & CO · 2006
  3. This deviceK082538 BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide…Becton, Dickinson & CO · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K020322BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO2002—
−1K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…Becton, Dickinson & CO2006—
0 (this device)K082538BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide…Becton, Dickinson & CO2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220
200810
FIG. 1 — Lineage of K082538, 2002–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K073653Sensititre 18 - 24 Hour Susceptibility Plate
Summary page 1
…Incubation Cycle Antimicrobial Susceptibility Device, 21 CFR 866.1645 PREDICATE DEVICES: Sensititre® Dtest (K073653) and BD Phoenix TM Automated Microbiology System with Gatifloxacin (K020321, May…
Trek Diagnostic Systems, Inc.2008—
*K020321BD Phoenix Automated Microbiology System
Summary page 1
…CATE DEVICES: Sensititre® Dtest (K073653) and BD Phoenix TM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), Ofloxacin…
Becton, Dickinson & CO20024
*K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent…
Summary page 1
…BD Phoenix TM Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322,…
Becton, Dickinson & CO2006—
*K020323BD Phoenix Automated Microbiology System
Summary page 1
…gy System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE:…
Becton, Dickinson & CO2002—
*K020322BD Phoenix Automated Microbiology System
Summary page 1
…23, 2002 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). INTENDED USE: The BD Phoenix TM Automated Mi…
Becton, Dickinson & CO2002—

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

DateClassRecallRoot causeReason
May 11, 2017Class IIZ-0171-2018Manufacturing material removalBD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
  • 1 of the 5 ancestors has a recall of any class.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LON

5in 2025

2007: 192008: 72009: 82010: 12011: 82012: 102013: 72014: 42016: 32017: 102018: 42019: 82020: 52021: 52022: 82023: 112024: 22025: 52026 (partial year): 4
2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007: 50 days median2008: 66 days median2009: 76 days median2011: 85 days median2012: 200 days median2013: 115 days median2014: 90 days median2016: 242 days median2017: 89 days median2018: 88 days median2019: 84 days median2020: 81 days median2021: 268 days median2022: 189 days median2023: 210 days median2025: 90 days median2026 (partial year): 146 days median
2007high 268 (2021) · low 50 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LON

1in 2025

2008: 12010: 1162011: 32012: 32014: 2, 2 Class I2016: 22017: 12018: 62019: 12020: 82022: 152024: 12025: 12026 (partial year): 6
2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007: 32008: 12010: 32011: 42012: 92013: 32014: 102015: 412016: 942017: 1972018: 5122019: 3152020: 2182021: 2322022: 1802023: 4532024: 4182025: 690
2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007195003
200876611
200987600
20101—1163
201188534
20121020039
2013711503
20144902 (2)10
20150—041
20163242294
201710891197
20184886512
20198841315
20205818218
202152680232
2022818915180
2023112100453
20242—1418
20255901690
202641466—

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 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 (96 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 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 the addition of the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species to Gram-positive ID/AST or AST only Phoenix panels. The Phoenix Inducible Macrolide Resistance Test is used to detect inducible macrolide-lincosamide-streptogramin B resistance in Staphylococcus species.

Indications for use as stated in the FDA summary.

More from Becton, Dickinson & CO

190 FDA decisions under this applicant name. See the company

  • K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
  • K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
  • K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 20141 recall
  • K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2014
  • K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2014

Recent decisions in LON

The LON category page

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025

https://510kreport.com/device/K082538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082538: BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082538

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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