FDA Product Code KTI: Bronchoscope Accessory
Under FDA product code KTI, bronchoscope accessories are cleared for use with bronchoscopic procedures in pulmonology and critical care.
These accessories include biopsy forceps, brushes, needles, suction catheters, and balloon catheters passed through the working channel of a bronchoscope to perform tissue sampling, foreign body removal, and therapeutic interventions within the airways.
KTI devices are Class II medical devices, regulated under 21 CFR 874.4680 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Olympus Medical Systems Corporation, Serpex Medical, Inc. and Free Flow Medical, Inc..
FDA 510(k) Cleared Bronchoscope Accessory Devices (Product Code KTI)
About Product Code KTI - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code KTI since 1978, with 33 receiving FDA clearance (average review time: 134 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under KTI have taken an average of 152 days to reach a decision - up from 130 days historically. Manufacturers should account for longer review timelines in current project planning.
KTI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →