Tubes, Vials, Systems, Serum Separators, Blood Collection

What Is FDA Product Code JKA?

Tubes, Vials, Systems, Serum Separators, Blood Collection is FDA product code JKA, Class 2, 21 CFR 862.1675.

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 14 clearances under this code; the FDA took a median of 177 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 170 recalls under this product code since 2002. None was by a company in China. 5 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (23), Process control (22) and Material/Component Contamination (21). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.