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 Corp., Serpex Medical, Inc. and Boston Scientific Corp.
33
Total
33
Cleared
134d
Avg days
1978
Since
Stable submission activity - 7 submissions in the last 2 years
Review times increasing: avg
152d
recently vs 130d historically
FDA 510(k) Cleared Bronchoscope Accessory Devices (Product Code KTI)
33 devices
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
Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
Boston Scientific Corporation
Ear, Nose, Throat
102d
Cleared
Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
Boston Scientific Corp
Ear, Nose, Throat
42d
Cleared
Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
Boston Scientific Corp
Ear, Nose, Throat
28d
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 510(k) Review Time - KTI Product Code
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 →