Cylinder, Compressed Gas, and Valve

What Is FDA Product Code ECX?

Cylinder, Compressed Gas, And Valve is FDA product code ECX, Class 1, 21 CFR 868.2700.

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 15 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (8), Device Design (6) and Component design/selection (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.