Attachment, Breathing, Positive End Expiratory Pressure

How Is BYE Classified?

Attachment, Breathing, Positive End Expiratory Pressure is FDA product code BYE, Class 2, 21 CFR 868.5965.

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. Chinese applicants hold 1 clearance under this code; the FDA took 112 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2007. 4 were by a company in China. The root causes the FDA records most often are Process design (4), Nonconforming Material/Component (3) and Device Design (3).

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