FDA applicant
Xiamen Blue Star Enterprise Co., Ltd.
FDA records 1 decision for Xiamen Blue Star Enterprise Co., Ltd. (Xiamen, CN) in 2022: 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 Xiamen Blue Star Enterprise 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 2022.
Planning a device like Xiamen Blue Star Enterprise 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