Dexcowin Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dexcowin Co., Ltd.” (first 2009, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 129 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 | 2 | 170 |
| 2015 | 1 | 300 |
| 2016 | 0 | — |
| 2017 | 1 | 28 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dexcowin Co., Ltd. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 64 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 4 | 4 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- Radiology (5)
Most recent Dexcowin Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173046 | Cocoon Portable Handheld X-Ray System | MUH | 2017-10-26 | 28 |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | IZL | 2015-10-05 | 300 |
| K134055 | ADX4000W | MUH | 2014-05-09 | 129 |
| K133007 | DX3000-L | MUH | 2014-04-24 | 211 |
| K083532 | ADX4000-L, DX3000-L | MUH | 2009-03-10 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Dexcowin Co., Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dexcowin Global, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dexcowin Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Dexcowin Co., Ltd.” (first 2009, latest 2017), 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 Dexcowin Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dexcowin Co., Ltd. is 129 days.
Which FDA product codes appear under Dexcowin Co., Ltd.?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 4); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 5 Dexcowin Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MUH, Dexcowin Co., Ltd.'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.