Media, Coupling, Ultrasound

What Is FDA Product Code MUI?

Media, Coupling, Ultrasound is FDA product code MUI, Class 2, 21 CFR 892.1570.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 57 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 6 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Employee error (2), No Marketing Application (1) and Nonconforming Material/Component (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.