Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

What Is FDA Product Code CBI?

Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) is FDA product code CBI, Class 2, 21 CFR 868.5740.

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 4 clearances under this code; the FDA took a median of 267 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2005. 2 were by a company in China. 4 are Class I, the most serious grade.

The root cause the FDA records most often is Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.