Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KFH · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | Immuno-Mycologics, Inc. | 1988-02-24 | 50 | 0 |
| K792685 | BLASTOMYCES DERMATITIDIS, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K792681 | BLASTOMYCES DERMATITIDIS POS/CONTROL | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K760833 | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | 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