Humidifier, Respiratory Gas, (Direct Patient Interface)

What Is FDA Product Code BTT?

Humidifier, Respiratory Gas, (Direct Patient Interface) is FDA product code BTT, Class 2, 21 CFR 868.5450.

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 70 recalls under this product code since 2004. None was by a company in China. 8 are Class I, the most serious grade.

The root causes the FDA records most often are Material/Component Contamination (15), Packaging change control (15) and Process control (13). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.