Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magnivision, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
379 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900777 | ITEM #273 CONTACT LENS CASES | Magnivision, Inc. | 1990-03-30 | 38 | 0 |
| K900778 | ITEM #272 MAGNIF-EYES CONTACT LENS CASE | Magnivision, Inc. | 1990-03-30 | 38 | 0 |
| K897085 | COMFEES(R) + CON-PAK(TM) LENS CASE | Magnivision, Inc. | 1990-02-28 | 70 | 0 |
| K897084 | CONFEES(R)+ CONTACT LENS HOLDER | Magnivision, Inc. | 1990-02-28 | 70 | 0 |
| K882384 | DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 | Magnivision, Inc. | 1989-06-23 | 379 | 0 |
| K890533 | ITEM #352/#CS352* CONTACT LENS CASES | Magnivision, Inc. | 1989-06-23 | 141 | 0 |
| K872567 | SOFT CONTACT LENS REMOVER | Magnivision, Inc. | 1987-08-10 | 42 | 0 |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | Magnivision, Inc. | 1987-08-04 | 34 | 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