CBI · Class II · 21 CFR 868.5740

FDA Product Code CBI: Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

Leading manufacturers include Cook, Inc., Pulmonx Corporation and Shenzhen Insighters Medical Technology Co., Ltd..

34
Total
34
Cleared
174d
Avg days
1985
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 206d recently vs 172d historically

FDA 510(k) Cleared Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) Devices (Product Code CBI)

34 devices
1–24 of 34
Cleared Mar 20, 2026
Endobronchial Blocker Tube (EBT0109)
K251950
Hangzhou Tappa Medical Technology Co., Ltd.
Anesthesiology · 268d
Cleared Feb 13, 2026
Chartis Precision Catheter
K253096
Pulmonx Corporation
Anesthesiology · 143d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529
Shenzhen Insighters Medical Technology Co., Ltd.
Anesthesiology · 266d
Cleared Dec 14, 2023
Disposable Endobronchial Blocker Tube
K232580
Shenzhen Insighters Medical Technology Co., Ltd.
Anesthesiology · 111d
Cleared Dec 01, 2022
Chartis Precision Catheter
K222340
Pulmonx Corporation
Anesthesiology · 120d
Cleared Aug 10, 2021
sOLVe Tube
K201026
Hytek Medical, Inc.
Anesthesiology · 477d
Cleared May 03, 2021
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
K203749
Ambu A/S
Anesthesiology · 131d
Cleared Dec 28, 2020
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
K200968
Insung Medical Co., Ltd.
Anesthesiology · 262d
Cleared Nov 14, 2018
VivaSight-DL System
K181886
Etview , Ltd.
Anesthesiology · 124d
Cleared Nov 02, 2018
Sheridan Endobronchial Tubes
K180253
Teleflex Medical
Anesthesiology · 276d
Cleared Aug 02, 2016
5.0 Fr Arndt Endobronchial Blocker Set
K160542
Cook Incorporated
Anesthesiology · 158d
Cleared Apr 15, 2015
RUSCH ENDOBRONCHIAL TUBES
K141888
Teleflexmedical, Inc.
Anesthesiology · 275d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920
Cook, Inc.
Anesthesiology · 64d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865
Cook, Inc.
Anesthesiology · 152d
Cleared Nov 21, 2001
RUSCH BRONCHUS BLOCKER KIT
K010596
Rusch Intl.
Anesthesiology · 266d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288
Cook, Inc.
Anesthesiology · 124d
Cleared Aug 29, 1997
BRONCHIAL BLOCKER
K962167
Cook, Inc.
Anesthesiology · 450d
Cleared Jul 31, 1996
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977
Kendall Healthcare Products Co. Div.Of Tyco Health
Anesthesiology · 72d
Cleared Mar 23, 1990
LASER RESISTANT TRACHEAL TUBE
K897046
Sheridan Catheter Corp.
Anesthesiology · 95d
Cleared May 23, 1985
TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
K851856
Sheridan Catheter Corp.
Anesthesiology · 27d

About Product Code CBI - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code CBI since 1985, with 34 receiving FDA clearance (average review time: 174 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - CBI Product Code

Recent submissions under CBI have taken an average of 206 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.

CBI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →