Device for Sealing Microsections

What Is FDA Product Code KIM?

Device For Sealing Microsections is FDA product code KIM, Class 1, 21 CFR 864.3400.

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 Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Process design (1).

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