FDA applicant
Xiamen Compower Medical Tech. Co., Ltd.
FDA records 3 decisions for Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN) from 2017 to 2026: 3 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CBP (Valve, Non-Rebreathing). Its devices cite 4 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 Xiamen Compower Medical Tech. 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 2017.
Planning a device like Xiamen Compower Medical Tech. 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