510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

K183415510(k) TraditionalCleared Feb 20, 201972-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

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

Cleared on Feb 20, 2019 as substantially equivalent to K172731 (bioMerieux, Inc., 2017) after a 72-day review. Its family tree reaches back 9 generations to 2003. 2 later devices descend from it. It has been recalled once.

Decided
Feb 20, 2019
Review
72 days
Class
Class II
Product code
LON
Recalls
1
Predicates
1

Its longest line of descent runs back 9 generations to K032788 (2003). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2021: 1 descendant clearedK032788 · 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. · 2012K161227 · VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) · bioMerieux, Inc. · 2016K172731 · VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) · bioMerieux, Inc. · 2017200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K172731 · VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) · bioMerieux, Inc. · 2017K161227 · VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) · bioMerieux, Inc. · 2016K121546 · 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 · 9 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 5 generations between
  3. 3 generations backK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
  4. 2 generations backK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
  5. 1 generation backK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
  6. This deviceK183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019
  7. Descendant · cites it directly · 1 of its ownK193572 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4…bioMerieux, Inc. · 2020
  8. Descendant · 2 generations on · 0 of its ownK211136 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc. · 2021 · Recalled
Show all 9 generations
  1. Root · 9 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 8 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
  3. 7 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
  4. 6 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
  5. 5 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
  6. 4 generations backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
  7. 3 generations backK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
  8. 2 generations backK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
  9. 1 generation backK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
  10. This deviceK183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc. · 2020 · cites it directly1descendant
  • K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K032788Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc.2003—
−8K041982Vitek 2 Gram Negative ErtapenembioMerieux, Inc.20041
−7K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc.2007—
−6K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc.2009—
−5K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc.2009—
−4K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc.2011—
−3K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.2012—
−2K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc.2016—
−1K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.2017—
0 (this device)K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.2019—
+1K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.2020—
+2K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
FIG. 1 — Lineage of K183415, 2003–2021Source: 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
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
*K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
Summary page 4
…Product Code: LON Common Name: VITEK® 2 AST-GN Imipenem C. Predicate Device: VITEK® 2 AST-GN Amikacin (K172731) D. 510(k) Summary: VITEK® 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram ne…
bioMerieux, Inc.2017—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.20201

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 5, 2026Class IIZ-1236-2026Under Investigation by firmPotential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K193572 (bioMerieux, Inc., 2020) has gone furthest, with 1 descendant of its own.

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

Read the full statement (136 words)

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

Acinetobacter spp.

Citrobacter spp.

E.cloacae / E.cloacae complex

Escherichia coli

Klebsiella spp.

Pseudomonas aeruginosa

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 as stated in the FDA summary.

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/K183415 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183415: VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183415

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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