Continuous, Ventilator, Home Use

What Is It?

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

What Is FDA Product Code NOU?

Continuous, Ventilator, Home Use is FDA product code NOU, Class 2, 21 CFR 868.5895.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 16 recalls under this product code since 2004. None was by a company in China. 4 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (5), Labeling design (3) and Process change control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.