Ventilator, Non-Continuous (Respirator)

What Is FDA Product Code BZD?

Ventilator, Non-Continuous (Respirator) is FDA product code BZD, 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 9 clearances under this code; the FDA took a median of 231 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 81 recalls under this product code since 2003. None was by a company in China. 30 are Class I, the most serious grade.

The root causes the FDA records most often are Environmental control (21), Device Design (20) and Error in labeling (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.