Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HZT — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
48 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883217 | SCHIFF REAGENT | Surgipath Medical Industries, Inc. | 1988-08-05 | 7 | 0 |
| K843752 | SIGMA PERIODIC ACID-SCHIFF STAIN 395 | Sigma Chemical Co. | 1984-10-30 | 35 | 0 |
| K842919 | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID | E K Ind., Inc. | 1984-09-11 | 48 | 0 |
| K842917 | SCHIFF REAGENT, PAS STAIN | E K Ind., Inc. | 1984-09-07 | 44 | 0 |
| K760031 | HISTOCHEMICAL PAS REACTION SET | Harleco | 1976-07-20 | 36 | 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