Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MDU — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | Immuno-Mycologics, Inc. | 2012-12-17 | 263 | 0 |
| K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN | Meridian Diagnostics, Inc. | 1991-01-25 | 122 | 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