Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KES · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882881 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER | Sakura Finetek U.S.A., Inc. | 1988-07-28 | 17 | 0 |
| K872874 | MICROSCOPE COVER GLASSES | Abco Dealers, Inc. | 1987-08-10 | 20 | 0 |
| K771925 | KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP | Harleco | 1977-11-02 | 19 | 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