FDA applicant
Mcube Technology Co., Ltd.
FDA records 6 decisions for Mcube Technology Co., Ltd. (Seoul, KR) from 2009 to 2020: 6 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 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 Mcube Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Mcube Technology 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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