510(k) Report

510(k) · Cleared

Cleared

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

K163637510(k) TraditionalCleared Mar 21, 201788-day reviewClass II21 CFR 866.1645

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

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

Cleared on Mar 21, 2017 as substantially equivalent to K121546 (bioMerieux, Inc., 2012) after an 88-day review. Its family tree reaches back 7 generations to 2003.

Decided
Mar 21, 2017
Review
88 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K032788 (2003). No later device cites it as a predicate yet.

K032788 · Vitek 2 Gram Negative Gatifloxacin · bioMerieux, Inc. · 2003K041982 · Vitek 2 Gram Negative Ertapenem · bioMerieux, Inc. · 2004 · recalledK072038 · Vitek 2 Gram Negative Levofloxacin · bioMerieux, Inc. · 2007K082346 · Vitek 2 Gram Negative Doripenem · bioMerieux, Inc. · 2009K091899 · Vitek 2 Gram Negative Meropenem · bioMerieux, Inc. · 2009K103752 · Vitek 2 Systems (PC) 5.02 Software · bioMerieux, Inc. · 2011K121546 · Vitek 2 Gram Negative Doxycycline · bioMerieux, Inc. · 20122000200520102015
K121546 · Vitek 2 Gram Negative Doxycycline · bioMerieux, Inc. · 2012K103752 · Vitek 2 Systems (PC) 5.02 Software · bioMerieux, Inc. · 2011K091899 · Vitek 2 Gram Negative Meropenem · bioMerieux, Inc. · 2009K082346 · Vitek 2 Gram Negative Doripenem · bioMerieux, Inc. · 2009K072038 · Vitek 2 Gram Negative Levofloxacin · bioMerieux, Inc. · 2007K041982 · Vitek 2 Gram Negative Ertapenem · bioMerieux, Inc. · 2004 · recalledK032788 · Vitek 2 Gram Negative Gatifloxacin · bioMerieux, Inc. · 2003−50
  1. Root · 7 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 6 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
  3. 5 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
  4. 4 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
  5. 3 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
  6. 2 generations backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
  7. 1 generation backK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
  8. This deviceK163637 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam…Becton Dickinson & Company · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K032788Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc.2003—
−6K041982Vitek 2 Gram Negative ErtapenembioMerieux, Inc.20041
−5K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc.2007—
−4K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc.2009—
−3K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc.2009—
−2K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc.2011—
−1K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.2012—
0 (this device)K163637BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4-…Becton Dickinson & Company2017—
FIG. 1 — Lineage of K163637, 2003–2017Source: 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? (1)

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
*K121546Vitek 2 Gram Negative Doxycycline
Summary page 5
…Antimicrobial Susceptibility System. (Product Code LON) PREDICATE DEVICES: VITEK®2 Gram Negative Doxycycline (K121546, November 20, 2012) INTENDED USE: The BD Phoenix Automated Microbi…
bioMerieux, Inc.2012—

Also cleared against K121546: 6 other devices →

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 14 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 6 other devices also cite its predicate K121546.

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. 2017, 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 Phoenix™ 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.…

Read the full statement (121 words)

The BD Phoenix™ 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.

Ceftazidime/avibactam 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

Citrobacter freundii complex

Citrobacter koseri

Escherichia coli

Enterobacter aerogenes

Enterobacter cloacae

Klebsiella pneumoniae

Klebsiella oxytoca

Proteus spp.

Pseudomonas aeruginosa

Active In Vitro but clinical significance is unknown

Morganella morganii

Providencia stuartii

Serratia marcescens

Indications for use as stated in the FDA summary.

Also cleared against K121546

6 other devices cite the same predicate.

  • K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, Inc. · 2017
  • K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)bioMerieux, Inc. · 2017
  • K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)bioMerieux, Inc. · 2017
  • K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc. · 20171 Class I recall
  • K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
  • K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc. · 20161 recall

More from Becton Dickinson & Company

2 FDA decisions under this applicant name. See the company

  • K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD…Becton Dickinson & Company · 2017

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/K163637 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163637: BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163637

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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