Tube, Tracheal (W/Wo Connector)

How Is BTR Classified?

Tube, Tracheal (W/Wo Connector) is FDA product code BTR, Class 2, 21 CFR 868.5730.

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 8 clearances under this code; the FDA took a median of 408 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 227 recalls under this product code since 2005. 1 was by a company in China. 169 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (58), Process change control (7) and Nonconforming Material/Component (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.