FDA applicant
Xiantao Rayxin Medical Products Co., Ltd.
FDA records 3 decisions for Xiantao Rayxin Medical Products Co., Ltd. (Xiantao, CN) from 2016 to 2022: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 113 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 Xiantao Rayxin Medical Products 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 2016.
Planning a device like Xiantao Rayxin Medical Products 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) ReportOther applicant names beginning “Xiantao”
FDA records each applicant name separately; these may or may not be the same firm.