MUI · Class II · 21 CFR 892.1570

FDA Product Code MUI: Media, Coupling, Ultrasound

Leading manufacturers include Pharmaceutical Innovations, Inc., Sonotech, Inc. and Sheathing Technologies, Inc..

35
Total
35
Cleared
175d
Avg days
1982
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 261d recently vs 167d historically

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

35 devices
1–24 of 35
Cleared Oct 30, 2026
AutoGel Pad (400-046,400-005)
K260575
Top-Rank Health Care Co., Ltd.
Radiology · 252d
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 Feb 16, 2011
DYNAREX ULTRASOUND GEL
K102637
Dynarex Corporation
Radiology · 155d
Cleared Jan 06, 2011
THE ADDITION
K102683
Ob The-Addition, LLC
Radiology · 111d
Cleared Jan 09, 2009
LUBRICANO-ULTRASOUND
K083358
Farco Pharma GmbH
Radiology · 87d

About Product Code MUI - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code MUI since 1982, with 35 receiving FDA clearance (average review time: 175 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - MUI Product Code

Recent submissions under MUI have taken an average of 261 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 →