Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GMG · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
51 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812189 | COCCIDIOIDES LATEX AGGLUTINATION | American Scientific Products | 1981-08-25 | 22 | 0 |
| K792690 | COCCIDIOIDES IMMITIS, LATEX AGGLUTI | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K791381 | COCCIDIODES (COCCI) | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K782070 | REAGENT, COCCI LATEX | I M, Inc. | 1979-02-01 | 51 | 0 |
| K760829 | COCCIDIOIDES MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 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