Computer, Diagnostic, Programmable

How Is DQK Classified?

Computer, Diagnostic, Programmable is FDA product code DQK, Class 2, 21 CFR 870.1425.

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 3 clearances under this code; the FDA took a median of 262 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 125 recalls under this product code since 2003. None 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 (37), Device Design (9) and Process control (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.