Syringe, Balloon Inflation, Exempt

What Is It?

This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

How Is PTM Classified?

Syringe, Balloon Inflation, Exempt is FDA product code PTM, Class 2, 21 CFR 870.1650.

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 7 recalls under this product code since 2021. None was by a company in China. The root causes the FDA records most often are Packaging process control (4), Device Design (1) and Process control (1).

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