Atlas FDA

CBI

34 FDA 510(k) clearances · Product code

140 daysmedian time to decision
276 days90th percentile
34clearances measured

FDA profile

Official device name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5740
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 159 · 2022: 127 · 2023: 95 · 2024: 75 · 2025: 85 · 2026: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (K251950)Hangzhou Tappa Medical Technology Co., Ltd.2026-03-20
Chartis Precision Catheter (K253096)Pulmonx Corporation2026-02-13
Disposable Double Lumen Endobronchial Tube (K232529)Shenzhen Insighters Medical Technology Co., Ltd.2024-05-13
Disposable Endobronchial Blocker Tube (K232580)Shenzhen Insighters Medical Technology Co., Ltd.2023-12-14
Chartis Precision Catheter (K222340)Pulmonx Corporation2022-12-01
sOLVe Tube (K201026)Hytek Medical, Inc.2021-08-10
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (K203749)Ambu A/S2021-05-03
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (K200968)Insung Medical Co., Ltd.2020-12-28
VivaSight-DL System (K181886)Etview , Ltd.2018-11-14
Sheridan Endobronchial Tubes (K180253)Teleflex Medical2018-11-02
5.0 Fr Arndt Endobronchial Blocker Set (K160542)Cook Incorporated2016-08-02
Endobronchial Tube (K152251)Henan Tuoren Medical Device Co., Ltd.2016-06-10
RUSCH ENDOBRONCHIAL TUBES (K141888)Teleflexmedical, Inc.2015-04-15
VIVASIGHT-DL SYSTEM (K123853)Etview , Ltd.2013-04-15
EZ-BLOCKER (K121462)Ez-Blocker B.V.2012-09-28
VIVA EB (K120334)Etview , Ltd.2012-06-08
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM (K113576)Etview , Ltd.2012-05-18
CHARTIS CATHETER MODEL CHR-CA-12.0 (K111522)Pulmonx, Inc.2011-09-29
COOPDECH ENDOBRONCHIAL BLOCKER TUBE (K093888)Daiken Medical Co, Ltd.2010-03-16
WELL LEAD ENDOBRONCHIAL TUBES (K092886)Well Lead Instruments2010-03-11
CHARTIS CATHETER (K083883)Pulmonx, Inc.2009-06-25
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX (K071694)Daiken Medical Co, Ltd.2008-03-20
SILBRONCHO DOUBLE LUMEN TUBE (K051522)Fuji Systems Corp.2005-08-17
7.0 FR. ENDOBRONCHIAL BLOCKER (K021920)Cook, Inc.2002-08-14
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER (K013865)Cook, Inc.2002-04-22
RUSCH BRONCHUS BLOCKER KIT (K010596)Rusch Intl.2001-11-21
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER (K002288)Cook, Inc.2000-11-28
BRONCHIAL BLOCKER (K962167)Cook, Inc.1997-08-29
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (K961977)Kendall Healthcare Products Co. Div.Of Tyco Health1996-07-31
SIMS BLUE LINE ENDOBRONCHIAL TUBE (K953483)Smiths Industries Medical Systems, Inc.1995-10-24
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (K925615)Sorin Biomedica, Fiat, USA, Inc.1993-03-26
LASER RESISTANT TRACHEAL TUBE (K897046)Sheridan Catheter Corp.1990-03-23
UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (K894337)Vitaid, Ltd.1989-09-29
TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE (K851856)Sheridan Catheter Corp.1985-05-23

Track CBI automatically

Every clearance here is in the API, with alerts when new ones post.