FDA product code MUI: Media, Coupling, Ultrasound
MUI is the FDA product code for media, coupling, ultrasound. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel. FDA has cleared 34 510(k) submissions under MUI, 6 in the last five years, from 26 different applicants. The average 510(k) review took 173 days (median 116); 156 days on average over the last three years. FDA has posted 6 recalls for MUI devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Media, Coupling, Ultrasound |
| Device class | Class II |
| Regulation | 21 CFR 892.1570 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MUI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 358 |
| 2018 | 5 | 352 |
| 2019 | 1 | 211 |
| 2021 | 1 | 203 |
| 2022 | 1 | 54 |
| 2023 | 1 | 85 |
| 2024 | 2 | 45 |
| 2026 | 2 | 266 |
Compare with all 510(k) review times · Search every MUI clearance
Top MUI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmaceutical Innovations, Inc. | 4 | 2018-01-09 |
| Sonotech, Inc. | 4 | 2004-11-05 |
| Hony Medical Co., Ltd. | 2 | 2024-07-24 |
| Sheathing Technologies, Inc. | 2 | 2013-02-06 |
| Foshan Pingchuang Medical Technology Co., Ltd. | 1 | 2026-06-17 |
21 more applicants have MUI clearances. See the full list in Caduvo.
Most recent MUI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253255 | Foshan Pingchuang Medical Technology Co., Ltd. | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | 2026-06-17 | 261 |
| K252337 | Edgecare, Inc. | EdgeFlow Gel Pad | 2026-04-24 | 270 |
| K242167 | Anhui Deepblue Medical Technology Co., Ltd. | Sterile and Non-Sterile Ultrasonic Coupling Agent | 2024-09-19 | 57 |
| K241789 | Hony Medical Co., Ltd. | Non-Sterile Ultrasound Transmission Gels | 2024-07-24 | 33 |
| K232957 | Jianerkang Medical Co., Ltd. | Sterile and Non-Sterile Ultrasound Gels | 2023-12-15 | 85 |
Recalls for MUI devices
6 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-07-07.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code MUI?
MUI is the FDA product code for media, coupling, ultrasound. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the Radiology panel.
What device class is MUI?
Class II, regulation 21 CFR 892.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUI?
Across 34 cleared submissions the average was 173 days from receipt to decision (median 116).
Which companies have the most MUI clearances?
Pharmaceutical Innovations, Inc. (4); Sonotech, Inc. (4); Hony Medical Co., Ltd. (2); Sheathing Technologies, Inc. (2); Foshan Pingchuang Medical Technology Co., Ltd. (1).
Have MUI devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2023-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MUI
- Run a recall and safety report across every MUI manufacturer
- Watch product code MUI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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