Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Visidyne Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811316 | TRISCAN, MODELS 38,40,41,43 & 45 | Visidyne Corp. | 1981-07-02 | 51 | 0 |
| K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Visidyne Corp. | 1981-06-09 | 85 | 0 |
| K810700 | CHROMOPS FM-100 COLOR VISION TESTER | Visidyne Corp. | 1981-04-10 | 25 | 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