Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HKN — 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) |
|---|---|---|---|---|---|
| K936205 | COMPREHENSIVE PHOROPTER, MDR-680 | Canon USA, Inc. | 1994-09-28 | 273 | 0 |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | Woodlyn, Inc. | 1987-12-23 | 22 | 0 |
| K782118 | FUL-VUE | American Optical Corp. | 1979-01-26 | 30 | 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