FDA applicant
Yadu Medical (Henan) Co., Ltd.
FDA records 3 decisions for Yadu Medical (Henan) Co., Ltd. (He Nan, CN) from 2025 to 2026: 3 510(k) clearances. All are in product code FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 195 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Yadu Medical (Henan) 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 2025.
Planning a device like Yadu Medical (Henan) 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