Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NPR — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
422 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250218 | Xpert® FII & FV | Cepheid | 2025-02-21 | 28 | 0 |
| K223046 | Xpert® FII & FV | Cepheid® | 2023-02-15 | 139 | 0 |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018-01-12 | 109 | 0 |
| K100943 | INVADER FACTOR II | Hologic, Inc. | 2011-06-02 | 422 | 0 |
| K033612 | FACTOR II (PROTHROMBIN) G20210A KIT | Roche Diagnostics Corp. | 2003-12-18 | 31 | 2 |
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