Tube, Tracheostomy (W/Wo Connector)

What Is FDA Product Code BTO?

Tube, Tracheostomy (W/Wo Connector) is FDA product code BTO, Class 2, 21 CFR 868.5800.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 73 recalls under this product code since 2003. 1 was by a company in China. 33 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (16), Process design (6) and Process control (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.