Wide Corporation: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Wide Corporation” (first 2003, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 53 days, against 115 days for all cleared 510(k)s in the same product codes. 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 | 6 | 66 |
| 2017 | 2 | 18 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 51 |
| 2022 | 2 | 53 |
| 2023 | 2 | 242 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wide Corporation took a median 53 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 14 | 14 |
| LLZ | System, Image Processing, Radiological | 6 | 6 |
Review panels
- Radiology (20)
Most recent Wide Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222719 | CX50N | PGY | 2023-05-09 | 243 |
| K222716 | MX50N | PGY | 2023-05-08 | 242 |
| K222722 | CW60N | PGY | 2022-10-31 | 53 |
| K222717 | CL24N | PGY | 2022-10-31 | 53 |
| K210493 | CX30N (CX30PQX) | PGY | 2021-04-14 | 54 |
| K210491 | CW120N | PGY | 2021-04-08 | 48 |
| K170781 | MX50N(MX50YQS) | PGY | 2017-04-04 | 20 |
| K170783 | CX50N(CX50YQS) | PGY | 2017-03-31 | 16 |
| K160354 | MX50T(MX50TQS) | PGY | 2016-05-02 | 84 |
| K160353 | MX50N(MX50YQS) | PGY | 2016-04-22 | 74 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wide Corporation.
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 Wide Corporation?
FDA lists 20 510(k) clearances under the applicant name “Wide Corporation” (first 2003, latest 2023), 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 Wide Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wide Corporation is 54 days. Since 2017: 53 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wide Corporation?
The most frequent FDA product codes under this applicant name are PGY (Display, Diagnostic Radiology, 14); LLZ (System, Image Processing, Radiological, 6).
Next steps
- See all 20 Wide Corporation clearances with predicates and recalls
- Run predicate analysis for product code PGY, Wide Corporation'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.