510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

K191766510(k) TraditionalCleared Aug 5, 201935-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 Aug 5, 2019 as substantially equivalent to K183524 (bioMerieux, Inc., 2019) after a 35-day review. Its family tree reaches back 1 generation to 2019. 7 later devices descend from it.

Decided
Aug 5, 2019
Review
35 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K183524 (2019). 7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2020: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2025: 1 descendant clearedK183524 · VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) · bioMerieux, Inc. · 2019201620182020202220242026
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K183524 · VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) · bioMerieux, Inc. · 20190
  1. Root · 1 generation backK183524 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc. · 2019
  2. This deviceK191766 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc. · 2019
  3. Descendant · cites it directly · 2 of its ownK213931 VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. · 2022
  4. Descendant · 2 generations on · 1 of its ownK222073 VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc. · 2023
  5. Descendant · 3 generations on · 0 of its ownK251579 VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  6. Descendant · cites it directly · 0 of its ownK222430 VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2…Biomerieux Sa, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK214023 VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc. · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2020: 12021: 12022: 22023: 22025: 1
2020high 2 (2022) · low 0 (2024)2026

Most influential descendants

Showing 5 of 7 · See all
  • K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc. · 2022 · cites it directly2descendants
  • K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc. · 2023 · 2 generations on1descendant
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025 · 3 generations on0descendants
  • K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4…Biomerieux Sa, Inc. · 2023 · cites it directly0descendants
  • K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)bioMerieux, Inc.2019—
0 (this device)K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)bioMerieux, Inc.2019—
+1K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.2022—
+2K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc.2023—
+3K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.2025—
+1K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN…Biomerieux Sa, Inc.2023—
+1K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202220
202320
202510
FIG. 1 — Lineage of K191766, 2019–2025Source: 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
*K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
Summary page 4
…Product Code LON Common Name: VITEK® 2 AST-GN Eravacycline C. Predicate Device: VITEK® 2 AST-GN Delafloxacin (K183524) 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 K183524: 1 other device →

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.20222
K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4…Biomerieux Sa, Inc.20230
K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)bioMerieux, Inc.20220
K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)bioMerieux, Inc.20210
K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)bioMerieux, Inc.20200

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?

  • Its one ancestor has no recall.
  • Of its descendants, K213931 (bioMerieux, Inc., 2022) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K183524.

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. 2019, 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 Eravacycline 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 Eravacycline is a quantitative test. Eravacycline has been shown to be active against most strains of the microorganisms listed below, according to…

Read the full statement (147 words)

VITEK® 2 AST-Gram Negative Eravacycline 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 Eravacycline is a quantitative test. Eravacycline 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:

Citrobacter freundii

Enterobacter cloacae

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

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

Citrobacter koseri

Klebsiella (Enterobacter) aerogenes

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 K183524

1 other device cites the same predicate.

  • K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)bioMerieux, Inc. · 20201 recall

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/K191766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191766: VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191766

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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