Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODW · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
199 daysmedian FDA review time
464 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | 2019-05-24 | 156 | 0 |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016-05-26 | 255 | 0 |
| K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT | Trimgen Corporation | 2009-02-06 | 464 | 0 |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Osmetech Molecular Diagnostics | 2008-07-17 | 199 | 0 |
| K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | Autogenomics, Incorporated | 2008-01-23 | 90 | 0 |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID T | Nanosphere, Inc. | 2007-09-17 | 178 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda