Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GOG — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071101 | TRU RSV | Meridian Bioscience, Inc. | 2007-10-18 | 182 | 0 |
| K021172 | RSV OIA | Thermo Biostar, Inc. | 2002-09-13 | 154 | 0 |
| K853278 | POLIO TYPE I CF ANTIGEN, & TYPE II, III | Hillcrest Biologicals | 1985-11-07 | 94 | 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