Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)

What Is FDA Product Code MWI?

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) is FDA product code MWI, 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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 22 clearances under this code; the FDA took a median of 163 days from receipt to decision on them.

3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 81 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software design (21), Device Design (17) and No Marketing Application (6).

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