510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

K211136510(k) TraditionalCleared Jun 14, 202159-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 Jun 14, 2021 as substantially equivalent to K193572 (bioMerieux, Inc., 2020) after a 59-day review. Its family tree reaches back 11 generations to 2003. It has been recalled once.

Decided
Jun 14, 2021
Review
59 days
Class
Class II
Product code
LON
Recalls
1
Predicates
1

Its longest line of descent runs back 11 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. · 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. · 2017K183415 · VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) · bioMerieux, Inc. · 2019 · recalledK193572 · VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) · bioMerieux, Inc. · 202020002005201020152020
K193572 · VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) · bioMerieux, Inc. · 2020K183415 · VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) · bioMerieux, Inc. · 2019 · recalledK172731 · 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. · 2003−10−50
  1. Root · 11 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 7 generations between
  3. 3 generations backK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
  4. 2 generations backK183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019 · Recalled
  5. 1 generation backK193572 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4…bioMerieux, Inc. · 2020
  6. This deviceK211136 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc. · 2021
Show all 11 generations
  1. Root · 11 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 10 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
  3. 9 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
  4. 8 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
  5. 7 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
  6. 6 generations backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
  7. 5 generations backK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
  8. 4 generations backK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
  9. 3 generations backK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
  10. 2 generations backK183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019 · Recalled
  11. 1 generation backK193572 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4…bioMerieux, Inc. · 2020
  12. This deviceK211136 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K032788Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc.2003—
−10K041982Vitek 2 Gram Negative ErtapenembioMerieux, Inc.20041
−9K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc.2007—
−8K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc.2009—
−7K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc.2009—
−6K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc.2011—
−5K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.2012—
−4K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc.2016—
−3K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.2017—
−2K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.20191
−1K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.2020—
0 (this device)K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc.2021—
FIG. 1 — Lineage of K211136, 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
*K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
Summary page 4
…VITEK® 2 AST-GN Imipenem/Relebactam C. Predicate Device: VITEK® 2 AST-GN Imipenem/Relebactam (K193572) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration…
bioMerieux, Inc.2020—

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
  • 2 of the 11 ancestors have a recall of any class.

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 Imipenem/Relebactam 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/Relebactam is a quantitative test. Imipenem/Relebactam has been shown to be active against most strains of the microorganisms listed…

Read the full statement (154 words)

VITEK® 2 AST-Gram Negative Imipenem/Relebactam 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/Relebactam is a quantitative test. Imipenem/Relebactam 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 calcoaceticus-baumannii complex

Klebsiella (Enterobacter) aerogenes

Enterobacter cloacae

Escherichia coli

Klebsiella pneumoniae

Pseudomonas aeruginosa

Citrobacter freundii

Klebsiella oxytoca

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

Citrobacter koseri

Enterobacter asburiae

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/K211136 · printed Nov 3, 2026

Cite this page

510(k) Report. “K211136: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211136

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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