Zhejiang Curaway Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Zhejiang Curaway Medical Technology Co., Ltd.” (first 2023, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 217 days. Since 2017 the median was 217 days, against 113 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 | 1 | 336 |
| 2024 | 2 | 276 |
| 2025 | 3 | 207 |
| 2026 | 1 | 192 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhejiang Curaway Medical Technology Co., Ltd. took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| OAB | Low Energy Direct Current Thermal Ablation System | 1 | 1 |
Review panels
Most recent Zhejiang Curaway Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260517 | Automatic Core Biopsy Instrument | KNW | 2026-08-28 | 192 |
| K244018 | Disposable Biopsy Needle | KNW | 2025-07-22 | 207 |
| K242322 | Bone Marrow Biopsy Needle | KNW | 2025-01-24 | 171 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | KNW | 2025-01-24 | 217 |
| K240758 | Radiofrequency Generator System, Cura RF Electrode | GEI | 2024-12-11 | 266 |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | GEI | 2024-05-30 | 286 |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | OAB | 2023-06-08 | 336 |
Recalls
openFDA lists no recalls under a recalling firm named Zhejiang Curaway 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 Kindly Medical Devices Co., Ltd. (5 510(k)s)
- Zhejiang Longterm Medical Technology Co., Ltd. (5 510(k)s)
- Zhejiang Soudon 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 Curaway Medical Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Zhejiang Curaway Medical Technology Co., Ltd.” (first 2023, latest 2026), across 3 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 Curaway Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhejiang Curaway Medical Technology Co., Ltd. is 217 days. Since 2017: 217 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhejiang Curaway Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); OAB (Low Energy Direct Current Thermal Ablation System, 1).
Next steps
- See all 7 Zhejiang Curaway Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Zhejiang Curaway 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.