Monitor, Breathing Frequency

How Is BZQ Classified?

Monitor, Breathing Frequency is FDA product code BZQ, Class 2, 21 CFR 868.2375.

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. 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 268 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2004. None was by a company in China. The root cause the FDA records most often is Employee error (1).

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