Cable, Transducer and Electrode, Patient, (Including Connector)

What Is FDA Product Code DSA?

Cable, Transducer And Electrode, Patient, (Including Connector) is FDA product code DSA, Class 2, 21 CFR 870.2900.

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 16 clearances under this code; the FDA took a median of 144 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. 2 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Process design (6), Labeling Change Control (2) and Device Design (2).

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