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 Surgical Technologies America, Olympus Medical Systems Corp. and Serpex Medical, Inc..
34
Total
34
Cleared
133d
Avg days
1978
Since
Growing category -
8 submissions in the last 2 years
vs 4 in the prior period
Consistent review times:
146d avg (recent)
FDA 510(k) Cleared Bronchoscope Accessory Devices (Product Code KTI)
34 devices
Cleared
Jul 24, 2026
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
Cook Ireland, Ltd.
Anesthesiology
98d
Cleared
Apr 16, 2026
ClearTip TBNA Type
Finemedix Co., Ltd.
Anesthesiology
338d
Cleared
Mar 12, 2026
LungFlow Basket Catheter
Free Flow Medical, Inc.
Anesthesiology
86d
Cleared
Dec 19, 2025
LIA-1 Catheter (542-1)
Leadoptik, Inc.
Anesthesiology
227d
Cleared
Oct 08, 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Serpex Medical, Inc.
Anesthesiology
28d
Cleared
Jul 29, 2025
Single Use Aspiration Needle (NA-201SX-4021)
Olympus Medical Systems Corporation
Anesthesiology
60d
Cleared
Mar 31, 2025
Disposable Grasping Forceps FG-52D/FG-54D
Olympus Medical Systems Corp.
Anesthesiology
61d
Cleared
Mar 04, 2025
Disposable Cytology Brush (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd.
Anesthesiology
266d
Cleared
Nov 15, 2023
METIC™- Airway Balloon Catheter
M/S Meril Life Sciences Pvt. , Ltd.
Ear, Nose, Throat
147d
Cleared
Sep 25, 2023
EndoCore
Praxis Medical, LLC
Anesthesiology
188d
Cleared
May 11, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
Ga Health Company Limited
Ear, Nose, Throat
99d
Cleared
Mar 01, 2023
Multistage Balloon Dilatation Catheter
Dongguan TT Medical, Inc.
Ear, Nose, Throat
222d
Cleared
Aug 25, 2022
Compass Steerable Needle
Serpex Medical, Inc.
Anesthesiology
121d
Cleared
Jul 20, 2022
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology
301d
Cleared
Mar 08, 2022
Elation Pulmonary Balloon Dilation Catheter
Merit Medical Systems, Inc.
Ear, Nose, Throat
137d
Cleared
Nov 24, 2021
Trachealator
Disa Medinotec
Ear, Nose, Throat
156d
Cleared
Mar 18, 2020
ViziShot 2 FLEX
Olympus Surgical Technologies America
Anesthesiology
90d
Cleared
Dec 10, 2019
Single Use Aspiration Needle
Olympus Medical Systems Corp.
Anesthesiology
307d
Cleared
Jul 03, 2018
PeriView FLEX
Olympus Surgical Technologies America
Ear, Nose, Throat
60d
Cleared
Sep 21, 2017
PeriView FLEX
Olympus Surgical Technologies America
Ear, Nose, Throat
147d
Cleared
Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
Boston Scientific Corporation
Ear, Nose, Throat
102d
Cleared
Apr 06, 2017
ViziShot 2 FLEX
Olympus Surgical Technologies America
Ear, Nose, Throat
115d
Cleared
Sep 01, 2016
Elation Pulmonary Balloon Dilation
Merit Medical Systems, Inc.
Ear, Nose, Throat
105d
Cleared
Jul 27, 2016
Dillard Airway Dilatation System
Intuit Medical Products, LLC
Ear, Nose, Throat
237d
About Product Code KTI - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code KTI since 1978, with 34 receiving FDA clearance (average review time: 133 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KTI Product Code
FDA review times for KTI submissions have been consistent, averaging 146 days recently vs 130 days historically.
KTI devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →