ZheJiang Decans Medical Devices Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “ZheJiang Decans Medical Devices Co., Ltd.” (first 2024, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 244 days. Since 2017 the median was 244 days, against 89 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 |
|---|---|---|
| 2024 | 2 | 84 |
| 2025 | 1 | 65 |
| 2026 | 8 | 252 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ZheJiang Decans Medical Devices Co., Ltd. took a median 244 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent ZheJiang Decans Medical Devices Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253046 | HERA Interlocking Intramedullary Nailing System | HSB | 2026-06-16 | 267 |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | NKG | 2026-06-02 | 249 |
| K253130 | Dione PEEK Screw System | MBI | 2026-05-27 | 244 |
| K252930 | AQUA Laminoplasty Systems | NQW | 2026-05-27 | 254 |
| K252776 | ARIES Anterior Cervical Plate Systems | KWQ | 2026-05-14 | 254 |
| K252542 | LEO Spinal System | NKB | 2026-04-29 | 260 |
| K253213 | SAGI Cervical Cage System | OVE | 2026-04-20 | 203 |
| K252774 | Uni-C Cervical Cage System | OVE | 2026-04-15 | 225 |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | MBI | 2025-01-31 | 65 |
| K242195 | Gemini Cervical Fusion Cage System | ODP | 2024-11-04 | 101 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named ZheJiang Decans Medical Devices 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 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 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 Decans Medical Devices Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “ZheJiang Decans Medical Devices Co., Ltd.” (first 2024, latest 2026), across 9 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 Decans Medical Devices Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ZheJiang Decans Medical Devices Co., Ltd. is 244 days. Since 2017: 244 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ZheJiang Decans Medical Devices Co., Ltd.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 11 ZheJiang Decans Medical Devices Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MBI, ZheJiang Decans Medical Devices 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.