Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PQA — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
291 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | 2026-07-16 | 192 | 0 |
| K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024-12-19 | 16 | 0 |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | 2024-11-25 | 28 | 0 |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Cepheid | 2023-10-19 | 160 | 0 |
| K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023-03-06 | 90 | 0 |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity Sy | Cepheid | 2022-06-07 | 47 | 0 |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity Sy | Cepheid | 2022-02-09 | 209 | 0 |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Colle | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 | 549 | 0 |
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 | 90 | 0 |
| K190452 | Aptima BV Assay | Hologic, Inc. | 2019-05-23 | 87 | 0 |
| K190472 | Aptima CV/TV Assay | Hologic, Inc. | 2019-05-16 | 79 | 0 |
| DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 | 291 | 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