Spirometer, Monitoring (W/Wo Alarm)

What Is FDA Product Code BZK?

Spirometer, Monitoring (W/Wo Alarm) is FDA product code BZK, Class 2, 21 CFR 868.1850.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 212 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Manufacturing material removal (2) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.