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 Sheathing Technologies, Inc..

34
Total
34
Cleared
173d
Avg days
1982
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 266d recently vs 167d historically

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

34 devices
1–24 of 34
Cleared Jun 17, 2026
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255
Foshan Pingchuang Medical Technology Co., Ltd.
Radiology · 261d
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
Cleared Oct 25, 2017
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050
Advance Medical Designs, Inc.
Radiology · 358d
Cleared Jan 13, 2016
Sonishield 100 Antimicrobial Ultrasound Gel
K151070
Quotient Medical
Radiology · 267d
Cleared Jun 18, 2014
KONIX STERILE GEL
K130581
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
Radiology · 470d
Cleared Jul 18, 2013
SOLID GEL PAD
K131905
Bluemtech
Radiology · 22d
Cleared Feb 06, 2013
SHEATHES STERILE ULTRASOUND GEL
K130041
Sheathing Technologies, Inc.
Radiology · 29d
Cleared Aug 30, 2012
THIXO-GEL ULTRASOUND SPRAY
K121311
Cloverline International Pharma Services GmbH
Radiology · 121d
Cleared Jun 22, 2012
SHEATHES ULTRASOND GEL
K112827
Sheathing Technologies, Inc.
Radiology · 268d
Cleared Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
K042619
Sonotech, Inc.
Radiology · 42d
Cleared Dec 08, 2003
AUTOGEL PAD
K031018
Rich-Mar Corp.
Radiology · 252d
Cleared May 16, 2002
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956
Microtek Medical, Inc.
Radiology · 52d
Cleared Apr 16, 1982
POLYSONIC ULTRASOUND LOTION
K827296
Parker Laboratories, Inc.
Radiology · 17d

About Product Code MUI - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code MUI since 1982, with 34 receiving FDA clearance (average review time: 173 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - MUI Product Code

Recent submissions under MUI have taken an average of 266 days to reach a decision - up from 167 days historically. Manufacturers should account for longer review timelines in current project planning.

MUI devices are reviewed by the Radiology panel. Browse all Radiology devices →