Ding Hwa Co., Ltd.: FDA clearances and approvals
Ding Hwa Co., Ltd. has 5 FDA 510(k) clearances (first 2008, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time: 112 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 158 |
| 2014 | 2 | 98 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 55 |
| 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, Ding Hwa Co., Ltd.'s cleared 510(k)s took a median 55 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 55 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 5 | 5 |
Review panels
Most recent Ding Hwa Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181398 | DV-300 Aspirator | JCX | 2018-07-23 | 55 |
| K140809 | CLIQ DV-300 ASPIRATOR | JCX | 2014-06-23 | 83 |
| K140031 | SUCTION PUMP | JCX | 2014-04-28 | 112 |
| K132308 | CLIQ DV-300 ASPIRATOR | JCX | 2013-12-30 | 158 |
| K080005 | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | JCX | 2008-04-24 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Ding Hwa Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ding Hwa Co., Ltd. have?
Ding Hwa Co., Ltd. has 5 FDA 510(k) clearances (first 2008, latest 2018), across 1 product code in 1 review panel.
How long does FDA take to clear Ding Hwa Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ding Hwa Co., Ltd.'s cleared 510(k)s is 112 days.
What devices does Ding Hwa Co., Ltd. make?
Its most frequent FDA product codes are JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 5).
Has Ding Hwa Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ding Hwa Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Ding Hwa Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JCX, Ding Hwa Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.