Visioncare Devices, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Visioncare Devices, Inc.” (first 1991, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 | 1 | 132 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 344 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Visioncare Devices, Inc. took a median 344 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 5 | 5 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Visioncare Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | HQE | 2022-08-10 | 344 |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | HQE | 2012-05-30 | 132 |
| K023939 | VELOCITY ADVANTAGE | HQE | 2003-04-17 | 142 |
| K971064 | BAYERS BIMANUAL I/A HANDPIECES | HQC | 1997-06-09 | 77 |
| K940746 | VIT CUTTER MODEL 94 | HQE | 1994-06-06 | 108 |
| K904909 | I/A VITROPHAGE MODEL YPR 2001 | HQE | 1991-01-28 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Visioncare Devices, Inc..
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 Visioncare Devices, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Visioncare Devices, Inc.” (first 1991, latest 2022), 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 Visioncare Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Visioncare Devices, Inc. is 120 days.
Which FDA product codes appear under Visioncare Devices, Inc.?
The most frequent FDA product codes under this applicant name are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 5); HQC (Unit, Phacofragmentation, 1).
Next steps
- See all 6 Visioncare Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, Visioncare Devices, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.