510(k) Report

510(k) · Cleared

Cleared

Vitek 2 Systems (PC) 5.02 Software

K103752510(k) TraditionalCleared Oct 14, 2011295-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 Oct 14, 2011 as substantially equivalent to K091899 (bioMerieux, Inc., 2009) after a 295-day review. Its family tree reaches back 5 generations to 2003. 1 of the 25 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.

Decided
Oct 14, 2011
Review
295 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K032788 (2003). 19 later devices descend from it, 2 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2022: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2017: 9 descendants cleared, 1 with a Class I recall12023: 3 descendants cleared2019: 1 descendant cleared2020: 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. · 2009200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 8 descendants, 1 with a Class I recall13 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K091899 · 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+5
  1. Root · 5 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
  2. 4 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
  3. 3 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
  4. 2 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
  5. 1 generation backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
  6. This deviceK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
  7. Descendant · cites it directly · 15 of its ownK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
  8. Descendant · 2 generations on · 5 of its ownK161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016
  9. Descendant · 3 generations on · 3 of its ownK172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017
  10. Descendant · cites it directly · 2 of its ownK220546 Colibrí SystemCopan Wasp Srl · 2022
  11. Descendant · 4 generations on · 2 of its ownK183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2012: 12016: 22017: 92019: 12020: 12021: 12022: 12023: 3
2012high 9 (2017) · low 0 (2013)2026

Class I recalls in this family

  • K161217 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64…2 generations on · 2017

Most influential descendants

Showing 5 of 19 · See all
  • K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012 · cites it directly15descendants
  • K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. · 2016 · 2 generations on5descendants
  • K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. · 2017 · 3 generations on3descendants
  • K220546Colibrí SystemCopan Wasp Srl · 2022 · cites it directly2descendants
  • K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 2019 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K032788Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc.2003—
−4K041982Vitek 2 Gram Negative ErtapenembioMerieux, Inc.20041
−3K072038Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc.2007—
−2K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc.2009—
−1K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc.2009—
0 (this device)K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc.2011—
+1K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.2012—
+2K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc.2016—
+3K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.2017—
+1K220546Colibrí SystemCopan Wasp Srl2022—
+4K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.20191

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201620
201791
201910
202010
202110
202210
202330
FIG. 1 — Lineage of K103752, 2003–2023Source: 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.

1 device in this family has a Class I recall. 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
*K091899Vitek 2 Gram Negative Meropenem
Summary page 1
…ty Device, 21 CFR 866.1645 Common Name: VITEK 2 AST-GN lmipenemn C. Predicate Device: VITEK 2 Gram Negative Meropenem K091899 0. 510(k) Summary: VITEF& 2 Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative…
bioMerieux, Inc.2009—

Also cleared against K091899: 1 other device →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.201215
K220546Colibrí SystemCopan Wasp Srl20222

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K121546 (bioMerieux, Inc., 2012) has gone furthest, with 15 descendants of its own.
  • 1 other device also cites its predicate K091899.

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. 2011, 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?

VITEKO 2 ON Imipenem is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 ON Imipenem is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems 5.02 Software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Imipenem has been shown to be active both in vitro and in clinical infections against most strains of the following…

Read the full statement (185 words)

VITEKO 2 ON Imipenem is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 ON Imipenem is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems 5.02 Software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Imipenem has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Acinetobacter spp. Morganella morganhi

Citrobacter spp. Proteus vulgaris

Enterobacter aerogenes Providencia retigeri

Eacherichia coli Pseudomonas aeruginosa

Kiebsiella spp. Serratia marcescens

Active in vitro but clinical significance unknown:

Providencia stuarii

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus app., Enterococcus app., Streptococcus agalactiae, S. pneurnoniae and clinically significant yeast. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.

Indications for use as stated in the FDA summary.

Also cleared against K091899

1 other device cites the same predicate.

  • K110106Vitek 2 Gram Negative Trimethoprim/SulfamethoazolebioMerieux, Inc. · 2011

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/K103752 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103752: Vitek 2 Systems (PC) 5.02 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103752

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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