Holding Chambers, Direct Patient Interface

What Is This Device?

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

How Is NVP Classified?

Holding Chambers, Direct Patient Interface is FDA product code NVP, Class 2, 21 CFR 868.5630.

How Does It Reach the US Market?

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 3 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Environmental control (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.