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Mcube Technology Co., Ltd.

FDA Regulatory Profile

Mcube Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 18, 2017 · NAI
Latest 510(k)
Aug 19, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 18, 2017Gangseo, Korea (The Republic Of)DevicesNo Action Indicated (NAI)3007740628

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K201995CUBEScan BioCon-1100Aug 19, 2020
K200749CUBEScan BioCon-900SMay 19, 2020
K200548CUBEScan BioCon-1100Mar 27, 2020
K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Jun 22, 2017
K111021CUBESCAN / BIOCON-700Apr 27, 2011
K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEMJun 18, 2009

FDA data resources