FDA applicant
Ge Hualun Medical Systems Co., Ltd.
FDA records 12 decisions for Ge Hualun Medical Systems Co., Ltd. (Beijing, CN) from 2015 to 2025: 12 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and OXO (Image-Intensified Fluoroscopic X-Ray System…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 76 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 9 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Hualun Medical Systems Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Ge Hualun Medical Systems Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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