FDA applicant
Sysmed (China) Co., Ltd.
FDA records 2 decisions for Sysmed (China) Co., Ltd. (Shenyang, CN) from 2018 to 2020: 2 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 2 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 Sysmed (China) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Sysmed (China) 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