Catheter, Continuous Flush

What Is FDA Product Code KRA?

Catheter, Continuous Flush is FDA product code KRA, Class 2, 21 CFR 870.1210.

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 4 clearances under this code; the FDA took a median of 223 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 96 recalls under this product code since 2003. None was by a company in China. 7 are Class I, the most serious grade.

The root causes the FDA records most often are Storage (24), Process control (8) and Packaging process control (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.