510(k) · Cleared
ClearedDensichek Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Sep 11, 2009 as substantially equivalent to K050002 (bioMerieux, Inc., 2005) after a 287-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Sep 11, 2009
- Review
- 287 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050002 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050002 Vitek 2 CompactbioMerieux, Inc. · 2005 · Recalled
- This deviceK083536 Densichek PlusbioMerieux, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK192110 Vitek DensichekbioMerieux, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK093224 Densicheck PlusbioMerieux, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050002 | Vitek 2 Compact | bioMerieux, Inc. | 2005 | 6 |
| 0 (this device) | K083536 | Densichek Plus | bioMerieux, Inc. | 2009 | — |
| +1 | K192110 | Vitek Densichek | bioMerieux, Inc. | 2019 | — |
| +1 | K093224 | Densicheck Plus | bioMerieux, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
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 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050002 | Vitek 2 CompactSummary page 1…robial Susceptibility Device, 21 CFR 866.1645 Common Name: DensiCHEK Plus C. Predicate Device: DensiChek (K050002, VITEK 2 Compact) D. 510(k) Summary: DensiCHEK m Plus is intended for use with the VITEK® and VITEKI 2 Systems to measure… | 2005 |
| * | — | VITEK 2 Compact Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 a recall.
- Of its descendants, K192110 (bioMerieux, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
The DensiCHEK m Plus instrument is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. DensiCHEK Plus is indicated for use with polystyrene and glass test tubes and the reading range is 0.0 - 4.0 McFarland. The DensiChek Plus has applications as an in vitro diagnostic device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083536: Densichek Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083536
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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