510(k) Report

510(k) · Cleared

Cleared

Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae

K053186510(k) TraditionalCleared Dec 1, 200517-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 Dec 1, 2005 as substantially equivalent to K031865 (bioMerieux, Inc., 2003) after a 17-day review. Its family tree reaches back 1 generation to 2003. 24 later devices descend from it.

Decided
Dec 1, 2005
Review
17 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K031865 (2003). 24 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2009: 1 descendant cleared2006: 1 descendant cleared2011: 5 descendants cleared2012: 7 descendants cleared2013: 3 descendants cleared2023: 2 descendants cleared2021: 1 descendant cleared2026: 2 descendants clearedReference device: K050002 · Vitek 2 Compact · bioMerieux, Inc. · 2005 · recalledK031865 · Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae · bioMerieux, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 12 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K031865 · Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae · bioMerieux, Inc. · 20030
  1. Root · 1 generation backK031865 Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc. · 2003
  2. This deviceK053186 Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005
  3. Descendant · cites it directly · 20 of its ownK063597 Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007
  4. Descendant · 2 generations on · 3 of its ownK112000 Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011
  5. Descendant · 3 generations on · 2 of its ownK232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
  6. Descendant · 2 generations on · 2 of its ownK121863 Vitek 2 Ast-ST CefotaximebioMerieux, Inc. · 2012
  7. Descendant · 2 generations on · 1 of its ownK122359 Vitek 2 Strptococcus CeftriaxonebioMerieux, Inc. · 2012

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22009: 12011: 52012: 72013: 32021: 12023: 22026: 2
2006high 7 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 24 · See all
  • K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007 · cites it directly20descendants
  • K112000Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011 · 2 generations on3descendants
  • K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…bioMerieux, Inc. · 2023 · 3 generations on2descendants
  • K121863Vitek 2 Ast-ST CefotaximebioMerieux, Inc. · 2012 · 2 generations on2descendants
  • K122359Vitek 2 Strptococcus CeftriaxonebioMerieux, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031865Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc.2003—
0 (this device)K053186Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc.2005—
+1K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc.2007—
+2K112000Vitek 2 Streptococcus PenicillinbioMerieux, Inc.2011—
+3K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc.2023—
+2K121863Vitek 2 Ast-ST CefotaximebioMerieux, Inc.2012—
+2K122359Vitek 2 Strptococcus CeftriaxonebioMerieux, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200910
201150
201270
201330
202110
202320
202620
FIG. 1 — Lineage of K053186, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K031865Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae
Summary page 1
…pneumoniae C. Predicate Device: VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae (K031865). D. 510(k) Summary: VITEK® 2 Gram Positive Telithromycin for Streptococcuspneumoniae is designed for antimicrobial susc…
bioMerieux, Inc.2003—
†K050002Vitek 2 CompactbioMerieux, Inc.20056

Also cleared against K031865: 1 other device →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc.200720
K083383Vitek 2 Gram Positive Erythromycin for Streptococcus PneumoniaebioMerieux, Inc.20090
K063623Vitek 2 Gram Positive Meropenem for Streptococcus PneumoniaebioMerieux, Inc.20070
K063492Vitek 2 Gram Positive Erythromycin for Streptococcus PneumoniaebioMerieux, Inc.20060

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, K063597 (bioMerieux, Inc., 2007) has gone furthest, with 20 descendants of its own.
  • 1 other device also cites its predicate K031865.

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.

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 Gram Positive Telithromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Telithromycin for Streptococcus pneumoniae is a qualitative test. It 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. The VITEKI 2 Antimicrobial Susceptibility Test (AST) is…

Read the full statement (106 words)

VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Telithromycin for Streptococcus pneumoniae is a qualitative test. It 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.

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

Indications for use as stated in the FDA summary.

Also cleared against K031865

1 other device cites the same predicate.

  • K051849Vitek 2 Gram Positive Ertapenem for Streptococcus PneumoniaebioMerieux, Inc. · 2005

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/K053186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053186: Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053186

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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