Device, Positive Pressure Breathing, Intermittent

What Is FDA Product Code NHJ?

Device, Positive Pressure Breathing, Intermittent is FDA product code NHJ, Class 2, 21 CFR 868.5905.

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. Chinese applicants hold 1 clearance under this code; the FDA took 270 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2022. None was by a company in China. 10 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (4), Device Design (4) and Process control (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.