FDA applicant
Alpinion Medical Systems Co., Ltd.
FDA records 26 decisions for Alpinion Medical Systems Co., Ltd. (Seoul, KR) from 2011 to 2023: 26 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 39 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 Alpinion Medical Systems Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
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