510(k) Report

510(k) · Cleared

Cleared

Vitek Densichek

K192110510(k) TraditionalCleared Oct 31, 201987-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 31, 2019 as substantially equivalent to K083536 (bioMerieux, Inc., 2009) after an 87-day review. Its family tree reaches back 2 generations to 2005.

Decided
Oct 31, 2019
Review
87 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K050002 (2005). No later device cites it as a predicate yet.

K050002 · Vitek 2 Compact · bioMerieux, Inc. · 2005 · recalledK083536 · Densichek Plus · bioMerieux, Inc. · 20092005201020152020
K083536 · Densichek Plus · bioMerieux, Inc. · 2009K050002 · Vitek 2 Compact · bioMerieux, Inc. · 2005 · recalled0
  1. Root · 2 generations backK050002 Vitek 2 CompactbioMerieux, Inc. · 2005 · Recalled
  2. 1 generation backK083536 Densichek PlusbioMerieux, Inc. · 2009
  3. This deviceK192110 Vitek DensichekbioMerieux, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K050002Vitek 2 CompactbioMerieux, Inc.20056
−1K083536Densichek PlusbioMerieux, Inc.2009—
0 (this device)K192110Vitek DensichekbioMerieux, Inc.2019—
FIG. 1 — Lineage of K192110, 2005–2019Source: 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
*K083536Densichek Plus
Summary page 4
…n Name: VITEK® DENSICHEK® C. Predicate Device: Predicate Device Name: DensiCHEK ® Plus Predicate Device Number: K083536 D. 510(k) Summary: E. Intended Use: The VITEK® DENSICHEK® instrument is an accessory intended for use with the VITEK® 2 System…
bioMerieux, Inc.2009—

Also cleared against K083536: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 10.1 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K083536.

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?

The VITEK DENSICHEK instrument is an accessory intended for use with the VITEK 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to the microorganism concentrations. VITEK DENSICHEK is intended for use with polystyrene tubes, and the reading range is 0.00 to 4.00 McFarland. The VITEK DENSICHEK has applications as an in vitro diagnostic medical device, or in an industry setting.

Indications for use as stated in the FDA summary.

Also cleared against K083536

1 other device cites the same predicate.

  • K093224Densicheck PlusbioMerieux, Inc. · 2009

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/K192110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192110: Vitek Densichek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192110

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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