Bronchoscope Accessory

What Is It?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code KTI?

Bronchoscope Accessory is FDA product code KTI, Class 2, 21 CFR 874.4680.

How Does It Reach the US Market?

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 266 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 12 recalls under this product code since 2012. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Device Design (7), Error in labeling (1) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.