Atlas FDA

JCT

45 FDA 510(k) clearances · Product code

99 daysmedian time to decision
234 days90th percentile
45clearances measured

FDA profile

Official device name
Prosthesis, Tracheal, Expandable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3720
Medical specialty
General, Plastic Surgery
Flags
Implant · Life-sustaining
Adverse events (MAUDE)
2021: 106 · 2022: 61 · 2023: 110 · 2024: 76 · 2025: 50 · 2026: 55
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
Ultraflex™ Tracheobronchial Stent System (K230269)Boston Scientific Corporation2023-07-14
Through the Scope Tracheal Stent System (K220424)Micro-Tech (Nanjing) Co., Ltd.2022-07-08
Tracheal Stent System (Y-Shaped) (K212403)Micro-Tech (Nanjing) Co., Ltd.2021-10-30
Tracheal Stent System (K202204)Micro-Tech (Nanjing) Co., Ltd.2021-09-01
HANAROSTENT Trachea/Bronchium (CCC) (K201342)M.I.Tech Co., Ltd.2020-12-31
AEROmini Tracheobronchial Stent System (K181200)Merit Medical Systems, Inc.2018-09-21
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL (K152842)Boston Scientific Corporation2016-05-19
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (K140382)Merit Medical Systems, Inc.2014-11-25
BONASTENT TRACHEAL / BRONCHIAL (K140472)Endochoice, Inc.2014-10-17
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (K141584)Boston Scientific Corporation2014-10-16
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (K121048)Boston Scientific Corp2012-08-03
AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K083625)Alveolus, Inc.2009-03-11
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM (K082284)Alveolus, Inc.2008-11-20
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K071604)Alveolus, Inc.2007-09-19
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX (K062511)Alveolus, Inc.2007-01-31
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT (K050832)Bard Peripheral Vascular, Inc.2005-07-07
ATRIUM ICAST COVERED STENT (K050814)Atrium Medical Corp.2005-05-06
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT (K041269)Atrium Medical Corp.2004-09-14
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K033990)Alveolus, Inc.2004-05-12
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K033053)Alveolus, Inc.2004-02-25
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K032744)Alveolus, Inc.2003-11-13
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM (K031641)Vascular Architects, Inc.2003-08-01
FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041)Bard Peripheral Vascular2003-06-19
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K030947)Alveolus, Inc.2003-05-15
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM (K030567)Vascular Architects, Inc.2003-03-24
VIATORR ENDOPROSTHESIS (K024178)W. L. Gore & Associates, Inc.2003-03-07
MODIFICATION TO VIABAHN ENDOPROSTHESIS (K023811)W. L. Gore & Associates, Inc.2002-12-10
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (K021901)Boston Scientific Scimed, Inc.2002-07-09
INTRACOIL SELF-EXPANDING PERIPHERAL STENT (K021563)Sulzer Intratherapeutics, Inc.2002-05-31
VIABAHN ENDOPROSTHESIS (K013648)W. L. Gore & Associates, Inc.2002-01-08
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM (K012544)Vascular Architects, Inc.2001-11-15
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM (K003100)Boston Scientific Corp2000-12-20
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM (K000001)Boston Scientific Scimed, Inc.2000-06-05
INTRACOIL STENT (K001257)Intratherapeutics, Inc.2000-05-18
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K992510)Boston Scientific Corp1999-11-18
INTRACOIL PERIPHERAL STENT (K990221)Intratherapeutics, Inc.1999-06-02
WALLSTENT ENDOPROSTHESIS (K982184)Boston Scientific Scimed, Inc.1998-07-21
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING (K980163)Boston Scientific Scimed, Inc.1998-03-13
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS (K964121)Boston Scientific Scimed, Inc.1996-12-04
ULTRAFLEX (K963241)Boston Scientific Corp1996-11-14
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS (K961507)Boston Scientific Scimed, Inc.1996-07-10
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS (K961296)Boston Scientific Scimed, Inc.1996-07-10
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS (K945494)Boston Scientific Scimed, Inc.1995-03-03
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION (K934116)Boston Scientific Scimed, Inc.1994-06-02
GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT (K891411)Cook, Inc.1991-12-18

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