Catheter, Urological

How Is KOD Classified?

Catheter, Urological is FDA product code KOD, Class 2, 21 CFR 876.5130.

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 1 clearance under this code; the FDA took 345 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 108 recalls under this product code since 2004. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (19), Package design/selection (16) and Component design/selection (16). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.