FDA applicant
Xingyu Medical Tech Co., Ltd.
FDA records 4 decisions for Xingyu Medical Tech Co., Ltd. (Weifang, CN) from 2021 to 2024: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Xingyu Medical Tech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Xingyu Medical Tech 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