Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NPQ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
341 daysmedian FDA review time
419 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100980 | INVADER FACTOR V | Hologic, Inc. | 2011-06-01 | 419 | 0 |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Illumina, Inc. | 2010-04-28 | 208 | 0 |
| K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPIN | Osmetech Molecular Diagnostics | 2010-04-22 | 120 | 0 |
| K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | Cepheid | 2009-09-18 | 417 | 0 |
| K060564 | INFINITI SYSTEM | AutoGenomics, Inc. | 2007-02-07 | 341 | 0 |
| DEN030005 | FACTOR V LEIDEN KIT | Roche Diagnostics Corp. | 2003-12-17 | 9 | 0 |
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