Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microvision, Inc. — 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) |
|---|---|---|---|---|---|
| K022186 | SCLERAL PLUGS, 19 AND 20 GAUGE | Microvision, Inc. | 2003-02-26 | 236 | 0 |
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | 2003-01-08 | 83 | 0 |
| K982462 | FIBER OPTIC ENDOILLUMINATION PROBE | Microvision, Inc. | 1998-09-14 | 61 | 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