FDA Product Code MUI: Media, Coupling, Ultrasound
Leading manufacturers include Hony Medical Co., Ltd., Anhui Deepblue Medical Technology Co., Ltd. and Edgecare, Inc..
FDA 510(k) Cleared Media, Coupling, Ultrasound Devices (Product Code MUI)
About Product Code MUI - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code MUI since 1982, with 33 receiving FDA clearance (average review time: 170 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MUI have taken an average of 120 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.
MUI devices are reviewed by the Radiology panel. Browse all Radiology devices →