Prosthesis, Tracheal, Expandable

What Is FDA Product Code JCT?

Prosthesis, Tracheal, Expandable is FDA product code JCT, Class 2, 21 CFR 878.3720.

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 3 clearances under this code; the FDA took a median of 144 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 61 recalls under this product code since 2004. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (42), Process control (7) and Labeling False and Misleading (7). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.