510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

K201675510(k) TraditionalCleared Jul 9, 2021385-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

bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Jul 9, 2021 as substantially equivalent to K191766 (bioMerieux, Inc., 2019) after a 385-day review. Its family tree reaches back 2 generations to 2019.

Decided
Jul 9, 2021
Review
385 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K183524 (2019). No later device cites it as a predicate yet.

K183524 · VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) · bioMerieux, Inc. · 2019K191766 · VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) · bioMerieux, Inc. · 20192016201820202022
K191766 · VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) · bioMerieux, Inc. · 2019K183524 · VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) · bioMerieux, Inc. · 20190
  1. Root · 2 generations backK183524 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc. · 2019
  2. 1 generation backK191766 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc. · 2019
  3. This deviceK201675 VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc.2019—
−1K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc.2019—
0 (this device)K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc.2021—
FIG. 1 — Lineage of K201675, 2019–2021Source: 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
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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
*K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
Summary page 4
…-GN Meropenem (≤0.25 - ≥16 μg/mL) C. Predicate Device: VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 – > 4 µg/mL) (K191766) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration…
bioMerieux, Inc.2019—

Also cleared against K191766: 4 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 2 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
  • None of the 2 ancestors has a recall.
  • 4 other devices also cite its predicate K191766.

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. 2021, 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?

VITEK® 2 AST-Gram Negative Meroepnem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA…

Read the full statement (180 words)

VITEK® 2 AST-Gram Negative Meroepnem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections:

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Pseudomonas aeruginosa

In vitro data are available, but clinical significance is unknown:

Citrobacter freundii

Citrobacter koseri

Enterobacter cloacae

Hafnia alvei

Klebsiella oxytoca

Morganella morganii

Serratia marcescens

The VITEK® 2 Gram-Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms listed on the FDA Susceptibility Test Interpretive Criteria website:

Acinetobacter spp.

The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K191766

4 other devices cite the same predicate.

  • K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL)…Biomerieux Sa, Inc. · 2023
  • K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. · 2022
  • K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc. · 2022
  • K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)bioMerieux, Inc. · 2020

More from bioMerieux, Inc.

281 FDA decisions under this applicant name. See the company

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K234012Vitek Compact ProbioMerieux, Inc. · 2025

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/K201675 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201675: VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201675

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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