Jiangsu Vedkang Medical Science and Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Jiangsu Vedkang Medical Science and Technology Co., Ltd.” (first 2022, latest 2024), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 202 days. Since 2017 the median was 202 days, against 171 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 |
|---|---|---|
| 2022 | 2 | 240 |
| 2023 | 2 | 222 |
| 2024 | 3 | 198 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jiangsu Vedkang Medical Science and Technology Co., Ltd. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Jiangsu Vedkang Medical Science and Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232825 | Disposable Sphincterotome | KNS | 2024-03-29 | 198 |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | GCA | 2024-02-26 | 171 |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | FGE | 2024-02-15 | 202 |
| K230598 | Stone Extraction Baskets | LQR | 2023-09-12 | 193 |
| K222146 | Disposable Endoscopic Hemoclip | PKL | 2023-03-28 | 251 |
| K220089 | Disposable Polyp Snare | FDI | 2022-09-22 | 254 |
| K213914 | Injection Needle | FBK | 2022-07-29 | 226 |
Recalls
openFDA lists no recalls under a recalling firm named Jiangsu Vedkang Medical Science and Technology 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.
- Jiangsu Caina Medical Co.,Ltd (15 510(k)s)
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (15 510(k)s)
- Jiangsu Cureguard Glove Co., Ltd. (11 510(k)s)
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Kangbao Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Micsafe Medical Technology Co., Ltd. (5 510(k)s)
- Jiangsu Intco Medical Equipment & Supply Co., Ltd. (4 510(k)s)
- Jiangsu Sunshine Plastic Products, Co., Ltd. (4 510(k)s)
- Jiangsu Intco Medical Products Co., Ltd. (3 510(k)s)
- Jiangsu Jaysun Glove Co., Ltd. (3 510(k)s)
- Jiangsu Shenli Medical Production Co., Ltd. (3 510(k)s)
- Jiangsu Alfa Glove Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jiangsu Vedkang Medical Science and Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Jiangsu Vedkang Medical Science and Technology Co., Ltd.” (first 2022, latest 2024), across 7 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 Jiangsu Vedkang Medical Science and Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Vedkang Medical Science and Technology Co., Ltd. is 202 days. Since 2017: 202 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangsu Vedkang Medical Science and Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FDI (Snare, Flexible, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 7 Jiangsu Vedkang Medical Science and Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FBK, Jiangsu Vedkang Medical Science and Technology 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.