Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GNT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
479 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAI | Zymetx, Inc. | 1996-06-17 | 479 | 0 |
| K913828 | QTEST INFLUENZA A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-09-23 | 28 | 0 |
| K902609 | DIRECTIGEN FLU A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-10 | 90 | 0 |
| K780272 | INFLUENZA HA ANTIGEN | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | Flow Laboratories, Inc. | 1978-02-28 | 11 | 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