Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ICF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Sigma Diagnostics, Inc. | 1986-12-22 | 35 | 0 |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | 1984-10-01 | 95 | 0 |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | 1982-06-03 | 15 | 0 |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | 1979-12-18 | 14 | 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