FDA applicant
Tianchang Kanghui Protective Products Co, Ltd.
FDA records 1 decision for Tianchang Kanghui Protective Products Co, Ltd. (Tianchan, CN) in 2021: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). Its devices cite 1 predicate, 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 Tianchang Kanghui Protective Products Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Tianchang Kanghui Protective Products…’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 “Tianchang”
FDA records each applicant name separately; these may or may not be the same firm.