Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GMN · 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) |
|---|---|---|---|---|---|
| K894261 | TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN | Microbix Biosystems, Inc. | 1989-10-16 | 117 | 0 |
| K864981 | TOXOPLASMA GONDII | Virion (U.S.), Inc. | 1987-10-30 | 312 | 0 |
| K791456 | AGGLUTINOTEST-TOXOPLASMOSIS | Volu Sol Medical Industries | 1979-09-24 | 49 | 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