510(k) Report

510(k) · Cleared

Recalled · 2012

BD Phoenix Automated Microbiology System-Vancomycin Gram Positive

K030677510(k) TraditionalCleared Apr 1, 200328-day reviewClass II21 CFR 866.1645Recalls 2

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 Apr 1, 2003 as substantially equivalent to K020321 (Becton, Dickinson & CO, 2002) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled 2 times.

Decided
Apr 1, 2003
Review
28 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. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2006: 1 descendant clearedK020322 · BD Phoenix Automated Microbiology System · Becton, Dickinson & CO · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K020322 · BD Phoenix Automated Microbiology System · Becton, Dickinson & CO · 20020
  1. Root · 1 generation backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
  2. This deviceK030677 BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveBecton, Dickinson & CO · 2003
  3. Descendant · cites it directly · 0 of its ownK060493 BD Phoenix Automated Microbiology System - Vancomycin-GP Detection…Becton, Dickinson & CO · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K060493BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa.Becton, Dickinson & CO · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020322BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO2002—
0 (this device)K030677BD Phoenix Automated Microbiology System-Vancomycin Gram PositiveBecton, Dickinson & CO2003—
+1K060493BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa.Becton, Dickinson & CO2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K030677, 2002–2006Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeP050510VITEK 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
*K020321BD Phoenix Automated Microbiology System
Summary page 1
…CATE DEVICES: VITEK@System (PMA No. N505 10) and BD PhoenixTM Automated Microbiology System with Gatifloxacin (K020321, May 23,2002), Ofloxacin (K020323, April 14,2002), and…
Becton, Dickinson & CO20024
*K020323BD Phoenix Automated Microbiology System
Summary page 1
…hoenixTM Automated Microbiology System with Gatifloxacin (K020321, May 23,2002), Ofloxacin (K020323, April 14,2002), and Levofloxacin (K020322, March 27,2002). INTENDED USE:…
Becton, Dickinson & CO2002—
*K020322BD Phoenix Automated Microbiology System
Summary page 1
…Gatifloxacin (K020321, May 23,2002), Ofloxacin (K020323, April 14,2002), and Levofloxacin (K020322, March 27,2002). INTENDED USE: The BD PhoenixTMAutomated Microbiology System is…
Becton, Dickinson & CO2002—

Also cleared against K020321: 102 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060493BD Phoenix Automated Microbiology System - Vancomycin-GP Detection of Vrsa.Becton, Dickinson & CO20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 10, 2012Not classifiedZ-1657-2012Nonconforming Material/ComponentBD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
Apr 10, 2012Not classifiedZ-1658-2012Nonconforming Material/ComponentBD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K060493 (Becton, Dickinson & CO, 2006) has gone furthest, with 0 descendants of its own.
  • 102 other devices also cite its predicate K020321.

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.

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 PhoenixTMAutomated 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 Stapltylococcus and Enterococcus. This premarket notification…

Read the full statement (116 words)

The BD PhoenixTMAutomated 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 Stapltylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent vancomycin at concentrations of 0.5-32 pg/mL to 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 antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Staphylococcus species

Enterococcus species

Indications for use as stated in the FDA summary.

Also cleared against K020321

102 other devices cite the same predicate.

  • K082852BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/MLBecton, Dickinson & CO · 2009
  • K082913BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/MLBecton, Dickinson & CO · 2008
  • K082538BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance TestBecton, Dickinson & CO · 20081 recall
  • K073433BD Phoenix Automated Microbiology System-Piperacillin (GN) -128 UG/MLBecton, Dickinson & CO · 2008
  • K070809BD Phoenix Automated Microbiology System-Minocycline (GP) 1-32 UG/MLBecton, Dickinson & CO · 20072 recalls
  • K071623BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN) 1/0.5-32/16 UG/MLBecton, Dickinson & CO · 2007

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/K030677 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030677: BD Phoenix Automated Microbiology System-Vancomycin Gram Positive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030677

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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