Tray, Catheterization, Sterile Urethral, With or Without Catheter (Kit)

How Is FCM Classified?

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) is FDA product code FCM, Class 2, 21 CFR 876.5130.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 43 recalls under this product code since 2005. 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 (7), Equipment maintenance (6) and Packaging (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.