Zhejiang Soudon Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zhejiang Soudon Medical Technology Co., Ltd.” (first 2023, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Since 2017 the median was 165 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 |
|---|---|---|
| 2023 | 2 | 85 |
| 2024 | 1 | 165 |
| 2025 | 0 | — |
| 2026 | 2 | 212 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhejiang Soudon Medical Technology Co., Ltd. took a median 165 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 |
| 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 Zhejiang Soudon Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon Catheter | GCA | 2026-05-08 | 231 |
| K253056 | Disposable Stone Extraction Basket | LQR | 2026-04-03 | 193 |
| K232450 | Disposable Hemostatic Clips | PKL | 2024-01-26 | 165 |
| K232442 | Disposable Endoscope Injection Needles | FBK | 2023-11-09 | 87 |
| K232476 | Disposable Sphincterotome | KNS | 2023-11-07 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Zhejiang Soudon Medical 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.
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (20 510(k)s)
- Zhejiang Chuangxiang Medical Technology Co., Ltd. (14 510(k)s)
- ZheJiang Decans Medical Devices Co., Ltd. (11 510(k)s)
- Zhejiang Curaway Medical Technology Co., Ltd. (7 510(k)s)
- Zhejiang Kindly Medical Devices Co., Ltd. (5 510(k)s)
- Zhejiang Longterm Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Kangkang Medical-Devices Co., Ltd. (4 510(k)s)
- Zhejiang Nysin Medical Co., Ltd. (4 510(k)s)
- Zhejiang Gongdong Medical Technology Co., Ltd. (3 510(k)s)
- Zhejiang Zhonglei Medical Technology Co. , Ltd. (3 510(k)s)
- Zhejiang Carebao Co., Ltd. (2 510(k)s)
- Zhejiang Geyi Medical Instrument Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhejiang Soudon Medical Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Zhejiang Soudon Medical Technology Co., Ltd.” (first 2023, latest 2026), across 5 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 Zhejiang Soudon Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhejiang Soudon Medical Technology Co., Ltd. is 165 days. Since 2017: 165 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhejiang Soudon Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, 1); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 1).
Next steps
- See all 5 Zhejiang Soudon Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FBK, Zhejiang Soudon Medical 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.