Product Code: MUI
FDA class 2
21 CFR 892.1570
Media, Coupling, Ultrasound
Radiology
Ultrasound Coupling Media is a substance (gel, liquid, or pad) applied between an ultrasound transducer and the patient's skin to eliminate air gaps and ensure efficient transmission of ultrasound waves during diagnostic or therapeutic ultrasound procedures. It is FDA Class 2, requiring 510(k) clearance, with product code MUI under 21 CFR 892.1570 in the Radiology specialty. The device is not an implant and is not life-sustaining.
510(k)s
32
FEI Numbers
23
Registration Numbers
23
Unique Applicants
25
Years Active
42
Basic Information
- Product Code
- MUI
- Device Class
- FDA class 2
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 32 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Sep 19, 2024 | Substantially Equivalent | Anhui Deepblue Medical Technology Co.,Ltd. |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Jul 24, 2024 | Substantially Equivalent | Hony Medical Co., Ltd. |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Dec 15, 2023 | Substantially Equivalent | Jianerkang Medical Co., Ltd |
| K221999 | Ultrasound Transmission Gels | Aug 30, 2022 | Substantially Equivalent | Hony Medical Co., Ltd. |
| K211691 | Ultrast Gel | Dec 22, 2021 | Substantially Equivalent | Ultrast, Inc. |
| K190591 | Safergel Sterile Ultrasound Gel | Oct 04, 2019 | Substantially Equivalent | Safersonic US, Inc. |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | Jun 13, 2018 | Substantially Equivalent | HR Pharmaceuticals, Inc. |
| K163027 | Ultra/Phonic Free Conductivity Gel | Jan 09, 2018 | Substantially Equivalent | PHARMACEUTICAL INNOVATIONS, INC. |
| K163026 | Ultra/Phonic Scanning Gel | Jan 09, 2018 | Substantially Equivalent | Pharmaceutical Innovations Inc. |
| K163024 | Ultra/Phonic Conductivity Gel | Jan 08, 2018 | Substantially Equivalent | PHARMACEUTICAL INNOVATIONS, INC. |
| K163023 | Other-Sonic Transmission Gel | Jan 08, 2018 | Substantially Equivalent | PHARMACEUTICAL INNOVATIONS, INC. |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Oct 25, 2017 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Jan 13, 2016 | Substantially Equivalent | Quotient Medical |
| K130581 | KONIX STERILE GEL | Jun 18, 2014 | Substantially Equivalent | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
| K131905 | SOLID GEL PAD | Jul 18, 2013 | Substantially Equivalent | BLUEMTECH |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | Feb 06, 2013 | Substantially Equivalent | SHEATHING TECHNOLOGIES, INC. |
| K121311 | THIXO-GEL ULTRASOUND SPRAY | Aug 30, 2012 | Substantially Equivalent | CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH |
| K112827 | SHEATHES ULTRASOND GEL | Jun 22, 2012 | Substantially Equivalent | SHEATHING TECHNOLOGIES, INC. |
| K102637 | DYNAREX ULTRASOUND GEL | Feb 16, 2011 | Substantially Equivalent | DYNAREX CORPORATION |
| K102683 | THE ADDITION | Jan 06, 2011 | Substantially Equivalent | OB THE-ADDITION, LLC |
| K083358 | LUBRICANO-ULTRASOUND | Jan 09, 2009 | Substantially Equivalent | FARCO PHARMA GMBH |
| K072515 | EMBRACE GEL | Sep 20, 2007 | Substantially Equivalent | ORISON CORPORATION |
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Nov 05, 2004 | Substantially Equivalent | SONOTECH, INC. |
| K033178 | ULTRABIO | Aug 04, 2004 | Substantially Equivalent | SONOTECH, INC. |
| K031018 | AUTOGEL PAD | Dec 08, 2003 | Substantially Equivalent | RICH-MAR CORP. |
| K031222 | SCANLUBE | Jul 23, 2003 | Substantially Equivalent | SONOTECH, INC. |
| K031894 | SCANTEC PAD | Jul 18, 2003 | Substantially Equivalent | SONOTECH, INC. |
| K030889 | ULTRAEKOGEL MODELS EK 2000 & EK 2001 | May 23, 2003 | Substantially Equivalent | INMED LTDA. |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | May 16, 2002 | Substantially Equivalent | MICROTEK MEDICAL, INC. |
| K021132 | UNI-PATCH ULTRASOUND COUPLING GEL | May 15, 2002 | Substantially Equivalent | THE LUDLOW COMPANY LP |
| K013212 | WAVELENGHT ULTRASOUND LOTION | Feb 25, 2002 | Substantially Equivalent | NATIONAL THERAPY PRODUCTS INC. |
| K827296 | POLYSONIC ULTRASOUND LOTION | Apr 16, 1982 | Substantially Equivalent | PARKER LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.