Sunny Medical Device (Shenzhen) Co., Ltd.: FDA clearances and approvals
Sunny Medical Device (Shenzhen) Co., Ltd. has 6 FDA 510(k) clearances (first 2012, latest 2020), across 5 product codes in 2 review panels. Median 510(k) review time: 292 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 115 |
| 2013 | 0 | — |
| 2014 | 1 | 364 |
| 2015 | 1 | 401 |
| 2016 | 2 | 292 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 252 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sunny Medical Device (Shenzhen) Co., Ltd.'s cleared 510(k)s took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Cardiovascular (5)
- General Hospital (1)
Most recent Sunny Medical Device (Shenzhen) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191827 | Sunmed Disposable Angio-Closure Pads | DXC | 2020-03-16 | 252 |
| K160190 | Sunmed Control Syringes | DXT | 2016-11-10 | 288 |
| K153685 | Sunmed Haemostatic Valves | DQX | 2016-10-13 | 296 |
| K140356 | SUMMED HIGH PRESSURE LINE | DQO | 2015-03-20 | 401 |
| K133795 | SUMMED INFLATION DEVICE KIT | MAV | 2014-12-12 | 364 |
| K120119 | SUNMED GUIDE WIRE | DQX | 2012-05-11 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Sunny Medical Device (Shenzhen) 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 Sunny Medical Device (Shenzhen) Co., Ltd. have?
Sunny Medical Device (Shenzhen) Co., Ltd. has 6 FDA 510(k) clearances (first 2012, latest 2020), across 5 product codes in 2 review panels.
How long does FDA take to clear Sunny Medical Device (Shenzhen) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Sunny Medical Device (Shenzhen) Co., Ltd.'s cleared 510(k)s is 292 days.
What devices does Sunny Medical Device (Shenzhen) Co., Ltd. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 2); DQO (Catheter, Intravascular, Diagnostic, 1); DXC (Clamp, Vascular, 1).
Has Sunny Medical Device (Shenzhen) Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sunny Medical Device (Shenzhen) Co., Ltd. Related entities may recall under other names.
Next steps
- See all 6 Sunny Medical Device (Shenzhen) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Sunny Medical Device (Shenzhen) 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.