Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HYK · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
50 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873107 | INSTANT HEMATOXYLIN | Shandon, Inc. | 1987-08-21 | 14 | 0 |
| K872498 | HARRIS HEMATOXYLIN | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | Accra Laboratories, Inc. | 1984-10-02 | 28 | 0 |
| K823328 | HARRIS HEMATOXYLIN | Accra Laboratories, Inc. | 1982-12-28 | 50 | 0 |
| K810733 | HARRIS HEMATOXYLIN | Surgipath | 1981-04-14 | 27 | 0 |
| K800324 | VOLU-SOL HARRIS HEMATOXYLIN | Volu Sol Medical Industries | 1980-02-22 | 10 | 0 |
| K781585 | HEMATOXYLIN STAIN HARRIS | Bioscientific | 1978-10-10 | 22 | 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