Stainer, Tissue, Automated

How Is KEY Classified?

Stainer, Tissue, Automated is FDA product code KEY, Class 1, 21 CFR 864.3800.

How Does It Reach the US Market?

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 5 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Component design/selection (2), Device Design (2) and Process control (1).

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