Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KSI — 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) |
|---|---|---|---|---|---|
| K820368 | LECTIN-A | American Dade | 1982-04-14 | 64 | 0 |
| K813413 | LECTIN H | American Dade | 1982-03-04 | 87 | 0 |
| K792582 | POLY-LEC SYSTEM | Gamma Biologicals, Inc. | 1980-01-16 | 33 | 0 |
| K792583 | GAMMA ARACHIS HYPOGEA LECTIN | Gamma Biologicals, Inc. | 1980-01-16 | 33 | 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