Electrocardiograph

What Is FDA Product Code DPS?

Electrocardiograph is FDA product code DPS, Class 2, 21 CFR 870.2340.

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 44 clearances under this code; the FDA took a median of 162 days from receipt to decision on them.

12 went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 1 was reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 98 recalls under this product code since 2003. 1 was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Software design (16), Device Design (12) and Use error (11). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.