Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HYJ — Predicate Candidate Screening
14 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
35 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K842740 | DELAFIELD HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-17 | 35 | 0 |
| K842741 | GILL HEMATOXYLIN STAIN | E K Ind., Inc. | 1984-08-15 | 33 | 0 |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Accra Laboratories, Inc. | 1983-06-08 | 65 | 0 |
| K822352 | HEMATOXYLIN STAIN SOLUTION | Fisher Scientific Co., LLC | 1982-08-16 | 10 | 0 |
| K821533 | HEMATOXYLIN I | Volu Sol Medical Industries | 1982-06-10 | 20 | 0 |
| K821540 | HEMATOXYLIN II | Volu Sol Medical Industries | 1982-06-10 | 17 | 0 |
| K821541 | HEMATOXYLIN III | Volu Sol Medical Industries | 1982-06-10 | 17 | 0 |
| K821320 | HEMATOXYLIN STAIN | Sigma Chemical Co. | 1982-06-02 | 29 | 0 |
| K821062 | HEMATOXYLIN SOLUTION | Sigma Chemical Co. | 1982-04-29 | 14 | 0 |
| K811802 | HEMATOXYLIN | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K810758 | GILL'S HEMATOXYLIN #1 | Surgipath | 1981-04-14 | 25 | 0 |
| K810759 | GILL'S HEMATOXYLIN #2 | Surgipath | 1981-04-14 | 25 | 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