Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Microoptical Corporation — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042923 | MD-6W WIRELESS CRITICAL DATA VIEWER | The Microoptical Corporation | 2004-12-17 | 56 | 0 |
| K040244 | MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 | The Microoptical Corporation | 2004-03-24 | 50 | 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