Monitor, Ultrasonic, Fetal

What Is FDA Product Code KNG?

Monitor, Ultrasonic, Fetal is FDA product code KNG, Class 2, 21 CFR 884.2660.

What Does It Take to Sell It in the United States?

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 21 clearances under this code; the FDA took a median of 198 days from receipt to decision on them.

3 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

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