Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mci Optonix, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953444 | MCI OPTONIX ECONOMY CASSETTE | Mci Optonix, Inc. | 1995-08-02 | 16 | 0 |
| K945039 | MCI OPTONIX CASSETTE OKAMOTO CASSETE | Mci Optonix, Inc. | 1994-11-22 | 39 | 0 |
| K941023 | RAREX GREEN FAST | Mci Optonix, Inc. | 1994-03-30 | 27 | 0 |
| K902039 | RAREX & OPTEX X-RAY SCREENS | Mci Optonix, Inc. | 1990-07-27 | 84 | 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