MUI · Class II · 21 CFR 892.1570

FDA Product Code MUI: Media, Coupling, Ultrasound

Leading manufacturers include Pharmaceutical Innovations, Inc., Hony Medical Co., Ltd. and Ultrast, Inc..

33
Total
33
Cleared
170d
Avg days
1982
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 120d recently vs 175d historically

FDA 510(k) Cleared Media, Coupling, Ultrasound Devices (Product Code MUI)

33 devices
1–24 of 33
Cleared Apr 24, 2026
EdgeFlow Gel Pad
K252337
Edgecare, Inc.
Radiology · 270d
Cleared Sep 19, 2024
Sterile and Non-Sterile Ultrasonic Coupling Agent
K242167
Anhui Deepblue Medical Technology Co., Ltd.
Radiology · 57d
Cleared Jul 24, 2024
Non-Sterile Ultrasound Transmission Gels
K241789
Hony Medical Co., Ltd.
Radiology · 33d
Cleared Dec 15, 2023
Sterile and Non-Sterile Ultrasound Gels
K232957
Jianerkang Medical Co., Ltd.
Radiology · 85d
Cleared Aug 30, 2022
Ultrasound Transmission Gels
K221999
Hony Medical Co., Ltd.
Radiology · 54d
Cleared Dec 22, 2021
Ultrast Gel
K211691
Ultrast, Inc.
Radiology · 203d
Cleared Oct 04, 2019
Safergel Sterile Ultrasound Gel
K190591
Safersonic Us, Inc.
Radiology · 211d
Cleared Jun 13, 2018
EcoVue Sterile and Non-Sterile Ultrasound Gels
K181363
H R Pharmaceuticals, Inc.
Radiology · 21d
Cleared Jan 09, 2018
Ultra/Phonic Scanning Gel
K163026
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 09, 2018
Ultra/Phonic Free Conductivity Gel
K163027
Pharmaceutical Innovations, Inc.
Radiology · 435d
Cleared Jan 08, 2018
Other-Sonic Transmission Gel
K163023
Pharmaceutical Innovations, Inc.
Radiology · 434d
Cleared Jan 08, 2018
Ultra/Phonic Conductivity Gel
K163024
Pharmaceutical Innovations, Inc.
Radiology · 434d

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 510(k) Review Time - MUI Product Code

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 →