FDA applicant
ZheJiang Decans Medical Devices Co., Ltd.
FDA records 11 decisions for ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing, CN) from 2024 to 2026: 11 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 235 days from receipt to decision, against 76 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided ZheJiang Decans Medical Devices Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like ZheJiang Decans Medical Devices Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report