FDA product code · Radiology · Class 2
MUI: Media, Coupling, Ultrasound
MUI is FDA's product code for "Media, Coupling, Ultrasound": a Class 2 device classified under 21 CFR 892.1570, reviewed by the Radiology panel.
510(k) review time for MUI
Across 13 510(k) clearances under MUI decided from 2018-01-01 to 2026-10-06, the median was 211 days from FDA receipt to decision. Half took between 57 and 434 days, and 80% were decided within 434 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 57 |
| Median | 211 |
| 75th percentile | 434 |
| 80th percentile | 434 |
| 90th percentile | 435 |
| Slowest | 435 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MUI in the public FDA record
| 510(k) clearances, all years | 34 |
|---|
Counts of records, not of devices or events. Adverse event reports for MUI are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MUI
4 FDA recognized consensus standards cite MUI, among them NEMA UD 2-2004 (R2009); IEC 60601-2-37 Edition 2.1 2015; IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-105 NEMA UD 2-2004 (R2009) — Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- 12-293 IEC 60601-2-37 Edition 2.1 2015 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION — Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- 12-380 IEC 60601-2-37 Edition 3.0 2024-07 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.