System, Network and Communication, Physiological Monitors

How Is MSX Classified?

System, Network And Communication, Physiological Monitors is FDA product code MSX, Class 2, 21 CFR 870.2300.

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. Chinese applicants hold 6 clearances under this code; the FDA took a median of 156 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 21 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Software design (10), Device Design (2) and Process control (1).

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