Product code MUH: 510(k) clearances and predicates
Product code MUH covers SOTA Cloud Smart Sensor (1.5). FDA lists 206 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
206 clearances on file under product code MUH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 11 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 so far | 1 |
Recent clearances
Newest MUH clearances in the FDA index, with applicant and decision date:
- K251793, SOTA Cloud Smart Sensor (1.5), applicant Sota Cloud Corp., decided 2026-03-03. FDA record
- K252570, EzSensor HD, EzSensor UHD, applicant Qpix Solutions, Inc., decided 2025-11-10. FDA record
- K250687, Cocoon Solo (DX-7020s), applicant Dexcowin Global, Inc., decided 2025-10-24. FDA record
- K251206, Digital X-Ray DentiMax Pro Imaging System, applicant Dentimax, Inc., decided 2025-09-24. FDA record
- K240040, VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan), applicant VATECH Co., Ltd., decided 2024-10-25. FDA record
- K242778, X Sensor (Model: IOS-A15IF, HDI-15DGF), applicant Qpix Solutions, Inc., decided 2024-10-11. FDA record
- K241649, DUO1 and DUO2, applicant Zinnovi, Inc., decided 2024-07-05. FDA record
- K232325, RAYSCAN a-Expert, applicant Ray Co., Ltd., decided 2024-04-18. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include EzSensor HD, EzSensor UHD, Cocoon Solo (DX-7020s). Watch new MUH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MUH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MUH clearances include SOTA Cloud Smart Sensor (1.5).
How many 510(k) clearances use product code MUH?
206 at the time this page was generated, from openFDA records.
How do I find a predicate device under MUH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MUH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.