Clinical Sample Concentrator

What Is FDA Product Code JJH?

Clinical Sample Concentrator is FDA product code JJH, Class 1, 21 CFR 862.2310.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 31 recalls under this product code since 0013. 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 (5), Process control (5) and Nonconforming Material/Component (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.