Wicab, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Wicab, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|
| 2015 | 1 | 86 |
| 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 |
|---|---|---|---|
| PIC | Oral Electronic Vision Aid | 2 | 1 |
Review panels
- Ophthalmic (2)
Most recent Wicab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152851 | BrainPort V100 | PIC | 2015-12-24 | 86 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130039 | De Novo | Oral Electronic Vision Aid | 2015-06-18 |
Recalls
openFDA lists no recalls under a recalling firm named Wicab, 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.
Device clinical trials
An industry sponsor named Wicab, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01488786: A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind (Completed, started 2011-10)
- NCT00768378: Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction. (Completed, started 2008-07)
- NCT00567944: Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke (Completed, started 2007-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wicab, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Wicab, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code 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 Wicab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wicab, Inc. is 86 days.
Which FDA product codes appear under Wicab, Inc.?
The most frequent FDA product codes under this applicant name are PIC (Oral Electronic Vision Aid, 2).
Next steps
- See all 1 Wicab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PIC, Wicab, 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.