FDA applicant
Wepon Medical Technology Co., Ltd.
FDA records 5 decisions for Wepon Medical Technology Co., Ltd. (Wenling, CN) from 2022 to 2023: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 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 Wepon Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Wepon Medical Technology Co., Ltd.’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