Magnivision, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Magnivision, Inc.” (first 1987, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LRX | Case, Contact Lens | 6 | 6 |
| KYE | Inserter/Remover Contact Lens | 2 | 2 |
Review panels
- Ophthalmic (8)
Most recent Magnivision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900778 | ITEM #272 MAGNIF-EYES CONTACT LENS CASE | LRX | 1990-03-30 | 38 |
| K900777 | ITEM #273 CONTACT LENS CASES | LRX | 1990-03-30 | 38 |
| K897085 | COMFEES(R) + CON-PAK(TM) LENS CASE | LRX | 1990-02-28 | 70 |
| K897084 | CONFEES(R)+ CONTACT LENS HOLDER | LRX | 1990-02-28 | 70 |
| K890533 | ITEM #352/#CS352* CONTACT LENS CASES | LRX | 1989-06-23 | 141 |
| K882384 | DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 | LRX | 1989-06-23 | 379 |
| K872567 | SOFT CONTACT LENS REMOVER | KYE | 1987-08-10 | 42 |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | KYE | 1987-08-04 | 34 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-05-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Magnivision, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Magnivision, Inc.” (first 1987, latest 1990), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Magnivision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Magnivision, Inc. is 56 days.
Which FDA product codes appear under Magnivision, Inc.?
The most frequent FDA product codes under this applicant name are LRX (Case, Contact Lens, 6); KYE (Inserter/Remover Contact Lens, 2).
Next steps
- See all 8 Magnivision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRX, Magnivision, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.