Media, Coupling, Ultrasound
FDA product code MUI · Class II (moderate risk) · 21 CFR 892.1570 · Radiology
34510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Pharmaceutical Innovations, Inc. 4
- Sonotech, Inc. 4
- Hony Medical Co., Ltd. 2
- Sheathing Technologies, Inc. 2
- Dynarex Corp. 1
- Foshan Pingchuang Medical Technology Co., Ltd. 1
- H R Pharmaceuticals, Inc. 1
- Advance Medical Designs, Inc. 1
- Quotient Medical 1
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa 1
- Bluemtech 1
- Cloverline International Pharma Services GmbH 1
- Parker Laboratories, Inc. 1
- Ob The-Addition, LLC 1
- Farco Pharma GmbH 1
- Orison Corporation 1
- Rich-Mar Corp. 1
- Inmed Ltda. 1
- Microtek Medical, Inc. 1
- The Ludlow Company LP 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound GelMUI · Traditional | Foshan Pingchuang Medical Technology Co., Ltd. | 06/17/2026SE |
| K252337 | EdgeFlow Gel PadMUI · Traditional | Edgecare, Inc. | 04/24/2026SE |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 09/19/2024SE |
| K241789 | Non-Sterile Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 07/24/2024SE |
| K232957 | Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | Jianerkang Medical Co., Ltd. | 12/15/2023SE |
| K221999 | Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 08/30/2022SE |
| K211691 | Ultrast GelMUI · Traditional | Ultrast, Inc. | 12/22/2021SE |
| K190591 | Safergel Sterile Ultrasound GelMUI · Traditional | Safersonic Us, Inc. | 10/04/2019SE |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | H R Pharmaceuticals, Inc. | 06/13/2018SE |
| K163027 | Ultra/Phonic Free Conductivity GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/09/2018SE |
| K163026 | Ultra/Phonic Scanning GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/09/2018SE |
| K163024 | Ultra/Phonic Conductivity GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/08/2018SE |
| K163023 | Other-Sonic Transmission GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/08/2018SE |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound GelMUI · Traditional | Advance Medical Designs, Inc. | 10/25/2017SE |
| K151070 | Sonishield 100 Antimicrobial Ultrasound GelMUI · Traditional | Quotient Medical | 01/13/2016SE |
| K130581 | Konix Sterile GelMUI · Traditional | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 06/18/2014SE |
| K131905 | Solid Gel PadMUI · Traditional | Bluemtech | 07/18/2013SE |
| K130041 | Sheathes Sterile Ultrasound GelMUI · Traditional | Sheathing Technologies, Inc. | 02/06/2013SE |
| K121311 | Thixo-Gel Ultrasound SprayMUI · Traditional | Cloverline International Pharma Services GmbH | 08/30/2012SE |
| K112827 | Sheathes Ultrasond GelMUI · Traditional | Sheathing Technologies, Inc. | 06/22/2012SE |
| K102637 | Dynarex Ultrasound GelMUI · Traditional | Dynarex Corporation | 02/16/2011SE |
| K102683 | The AdditionMUI · Traditional | Ob The-Addition, LLC | 01/06/2011SE |
| K083358 | Lubricano-UltrasoundMUI · Traditional | Farco Pharma GmbH | 01/09/2009SE |
| K072515 | Embrace GelMUI · Traditional | Orison Corporation | 09/20/2007SE |
| K042619 | Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging CouplantMUI · Special | Sonotech, Inc. | 11/05/2004SE |
| K033178 | UltrabioMUI · Traditional | Sonotech, Inc. | 08/04/2004SE |
| K031018 | Autogel PadMUI · Traditional | Rich-Mar Corp. | 12/08/2003SE |
| K031222 | ScanlubeMUI · Traditional | Sonotech, Inc. | 07/23/2003SE |
| K031894 | Scantec PadMUI · Special | Sonotech, Inc. | 07/18/2003SE |
| K030889 | Ultraekogel Models Ek 2000 & Ek 2001MUI · Traditional | Inmed Ltda. | 05/23/2003SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | Microtek Medical, Inc. | 05/16/2002SE |
| K021132 | Uni-Patch Ultrasound Coupling GelMUI · Traditional | The Ludlow Company LP | 05/15/2002SE |
| K013212 | Wavelenght Ultrasound LotionMUI · Traditional | National Therapy Products, Inc. | 02/25/2002SE |
| K827296 | Polysonic Ultrasound LotionMUI · Traditional | Parker Laboratories, Inc. | 04/16/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2533-2023 Class II | 50-GEL20; Ultrasound gelUltrasound gel mislabeled with inappropriate use. | Advance Medical Designs, Inc. | 07/07/2023Open, Classified |
| Z-2532-2023 Class II | ASG-001; Ultrasound gelUltrasound gel mislabeled with inappropriate use. | Advance Medical Designs, Inc. | 07/07/2023Open, Classified |
| Z-0777-2024 Class II | REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE…Sterility of Ultrasound gel can not be guaranteed. | Turkuaz Saglik Hizmetleri Medikal Temizlik… | 06/09/2023Open, Classified |
| Z-2830-2020 Class II | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028…The firm registered the product as a Class I device, but has since been informed by FDA that the device is… | Pharmaceutical Innovations, Inc. | 08/13/2020Terminated |
| Z-1653-2012 | Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is…Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination.… | Pharmaceutical Innovations, Inc. | 03/02/2012Terminated |
| Z-1652-2012 | Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a…Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination.… | Pharmaceutical Innovations, Inc. | 03/02/2012Terminated |