Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HYF · 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) |
|---|---|---|---|---|---|
| K842742 | GIEMSA STAIN | E K Ind., Inc. | 1984-08-15 | 33 | 0 |
| K833665 | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | J.S. Medical Assoc. | 1983-11-25 | 38 | 0 |
| K833677 | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | J.S. Medical Assoc. | 1983-11-25 | 38 | 0 |
| K831131 | CASE WRIGHT-GIEMSA STAIN PAK | Case Instruments | 1983-06-08 | 63 | 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