FDA applicant
Wuhan Dymex Healthcare Co., Ltd.
FDA records 4 decisions for Wuhan Dymex Healthcare Co., Ltd. (Wuhan, CN) from 2019 to 2022: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYC (Gown, Isolation, Surgical). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Wuhan Dymex Healthcare Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Wuhan Dymex Healthcare 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