MUI
- Product code
- MUI
- Device name
- Media, Coupling, Ultrasound
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1570
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253255 | 2026-06-17 | Foshan Pingchuang Medical Technology C | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | |
| K252337 | 2026-04-24 | Edgecare, Inc. | EdgeFlow Gel Pad | FDA |
| K242167 | 2024-09-19 | Anhui Deepblue Medical Technology Co., | Sterile and Non-Sterile Ultrasonic Coupling Agent | |
| K241789 | 2024-07-24 | Hony Medical Co., Ltd. | Non-Sterile Ultrasound Transmission Gels | |
| K232957 | 2023-12-15 | Jianerkang Medical Co., Ltd. | Sterile and Non-Sterile Ultrasound Gels |
Official FDA classification page: MUI
Classification and pathway per current FDA publications. Data from openFDA (CC0).