510(k) · Cleared
ClearedEsensor Warfarin Sensitivity Saliva Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GenMark Diagnostics, Inc. · NSU Instrumentation For Clinical Multiplex Test Systems
Cleared on Dec 2, 2011 as substantially equivalent to K073720 (Osmetech Molecular Diagnostics, 2008) after a 255-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Dec 2, 2011
- Review
- 255 days
- Class
- Class II
- Product code
- NSU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073720 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK073720 Esensor Warfarin Sensitivity and XT-8 InstrumentOsmetech Molecular Diagnostics · 2008
- This deviceK110786 Esensor Warfarin Sensitivity Saliva TestGenMark Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK152612 eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated · 2016
Most influential descendants
Showing 1 of 1 · See all- K152612eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073720 | Esensor Warfarin Sensitivity and XT-8 Instrument | Osmetech Molecular Diagnostics | 2008 | — |
| 0 (this device) | K110786 | Esensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics, Inc. | 2011 | — |
| +1 | K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 NSU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073720 | Esensor Warfarin Sensitivity and XT-8 InstrumentSummary page 2…tivity Test is for in vitro diagnostic use within a licensed laboratory, as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Predicate devices: K073720 eSensor Warfarin Sensitivity Test eSensor XT-8 System Device Description: The eSensor® Warfarin Sensitivity Saliva Test is a mu… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152612 | eSensor Warfarin Sensitivity Saliva Test | 2016 | 0 |
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?
How does its category compare?
All NSU devicesNSU Instrumentation For Clinical Multiplex Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NSU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NSU
77in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NSU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSU
18in 2025
MAUDE reports naming product code NSU, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 85 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 3 | 77 | 0 | 30 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 4 | 3 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 24 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from human saliva samples collected using the the Oragene® Dx Device, as an aid in the identification of patients at risk for increased warfarin sensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110786: Esensor Warfarin Sensitivity Saliva Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110786
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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