Atlas FDA

BTR

241 FDA 510(k) clearances · Product code

87 daysmedian time to decision
294 days90th percentile
241clearances measured

FDA profile

Official device name
Tube, Tracheal (W/Wo Connector)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5730
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 1,329 · 2022: 1,132 · 2023: 1,330 · 2024: 1,678 · 2025: 1,819 · 2026: 955
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
Spiro-VISTA (K253437)Spiro Robotics2026-06-12
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) (K250173)Covidien, LLC2025-10-06
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced (K243785)Covidien, LLC2025-09-25
AeroJet Ventilation Catheter (K243579)Pipeline Medical Products, LLC2025-08-13
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499)William Cook Europe Aps2025-06-11
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (K250243)Flexicare Medical Limited.2025-05-20
LMA Fastrach ETT SU (K242495)Teleflex Medical2025-04-29
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (K241451)Teleflex Incorporated2025-02-11
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (K233341)Covidien, LLC2024-05-20
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) (K223130)Covidien2023-08-30
Wei Nasal Jet Tube (K211543)Well Lead Medical Co., Ltd.2022-07-21
Tenax Laser Resistant Endotracheal Tube (K213028)Bryan Medical, Inc.2021-10-21
Tenax Laser Resistant Endotracheal Tube (K200761)Bryan Medical, Inc.2020-11-25
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm (K192120)Venner Medical (Singapore) Pte, Ltd.2020-02-14
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff (K190878)Salter Labs, Inc.2020-01-10
Endotracheal Tube with Evacuation Lumen (K182739)Well Lead Medical Co., Ltd.2019-12-11
Sheridan Spiral-Flex Endotracheal Tubes (K192324)Teleflexmedical, Inc.2019-12-06
SolidAIRity III Airway Stabilization System (K190630)Securisyn Medical, LLC2019-10-09
Yikang Endotracheal Tube (K190213)Jiangxi Yikang Medical Instrument Group Co., Ltd.2019-09-06
Endotracheal Tube (K190274)Tianjin Medis Medical Device Co., Ltd.2019-07-30
VivaSight-SL (TVT) system (K181880)Etview , Ltd.2018-11-29
Frova Intubating Introducer (K171917)Cook Incorporated2018-04-23
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet (K172208)Nevap, Inc.2018-02-16
Endotracheal tube; Reinforced Endotracheal tube (K170234)Zhanjiang Star Enterprise Co., Ltd.2018-01-17
IRRIS (Infra-Red-Red Intubation System) (K171411)A.R Guide IN Medical , Ltd.2018-01-12
Frova Intubating Introducer (K161813)William Cook Europe Aps2017-05-19
Disposable Endotracheal tube, sterile, AccuCuff (K160694)Tianjin Medis Medical Device Co., Ltd.2017-04-07
ETView VivaSight-SL (TVT) system (K152438)Etview , Ltd.2016-02-25
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (K151381)Covidien2015-12-11
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube (K150603)Teleflexmedical, Inc.2015-11-27
RHINOGUARD (K141747)Davis Medical2015-04-20
DISPOSABLE TRACHEAL TUBE (K140228)Suzhou Weikang Medical Apparatus Co., Ltd.2014-12-18
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET (K141939)Teleflexmedical, Inc.2014-11-24
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE (K132415)Teleflexmedical, Inc.2014-06-06
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (K131254)Kimberly-Clark Corp.2013-08-20
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (K120985)Kimberly-Clark Corp.2012-12-19
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE (K111401)Hangzhou Bever Medical Devices Co., Ltd.2012-07-19
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) (K111406)Hangzhou Bever Medical Devices Co., Ltd.2012-07-19
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) (K121028)Etview , Ltd.2012-06-21
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS (K113333)Kimberly-Clark Corporation2012-05-11
AMBU ASCOPE 2 (K110962)Ambu A/S2011-11-18
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL (K110269)Well Lead Medical Co., Ltd.2011-08-26
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE (K100546)Parkermedicalinc2010-06-03
AMBU ASCOPE AND MONITOR (K093186)Ambu A/S2010-04-16
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE (K093135)Venner Medical (Singapore) Pte, Ltd.2010-04-02
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT (K091761)Teleflexmedical, Inc.2009-10-29
EZC MEDICAL, LLC INTUBAIDFLEX (K090777)Ezc Medical, LLC2009-08-04
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 (K083119)Smiths Medical Asd, Inc.2009-06-26
FLEXICARE MEDICAL ENDOTRACHEAL TUBES (K091591)Flexicare Medical, Ltd.2009-06-17
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V (K082038)Clarus Medical, LLC2009-04-28
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES (K090352)Covidien2009-04-03
ENDOTRACHEAL TUBE (K080105)Chilecom Medical Devices Co., Ltd.2009-02-13
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (K080339)Medsource International, LLC2008-10-27
TRACHEOSCOPIC VENTILATION TUBE (TVT) (K082420)Etview2008-10-08
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (K082520)Mallinckrodt Medical2008-10-02
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 (K081086)Smiths Medical Asd, Inc.2008-08-13
WELL LEAD REINFORCED ENDOTRACHEAL TUBE (K073383)Well Lead Medical Instruments2008-07-10
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE (K080821)Kimberly-Clark Corp.2008-04-22
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) (K080170)C.R. Bard, Inc.2008-03-25
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (K071365)C.R. Bard, Inc.2007-11-06
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES (K060094)Arcadia Medical Corporation2006-05-08
LMA FASTRACH ETT SINGLE USE (K051993)The Laryngeal Mask Co., Ltd.2005-12-13
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM (K052233)Etview , Ltd.2005-12-13
AMSINO ENDOTRACHEAL TUBE (K050785)Amsino International, Inc.2005-07-15
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES (K050803)Vitaid, Ltd.2005-06-30
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) (K041311)Tiger Medical Products, Ltd.2005-03-18
WELL LEAD ENDOTRACHEAL TUBE (K042683)Well Lead Medical Instruments2005-02-18
RUSCH EASY TUBE (K043205)Teleflex Medical2005-01-07
PLASIATEK ACTUATOR (K041917)Plasiatek, LLC2005-01-07
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 (K040657)Vygon SA2004-06-10
ENDOFLEX TRACHEAL TUBE (K031794)Merlyn Associates, Inc.2004-03-12
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (K032112)Portex , Ltd.2004-01-26
BARD ENDOTRACHEAL TUBE, CUFFED (K030792)C.R. Bard, Inc.2003-11-14
RUSCH MICROLARYNGEAL TUBE (K023964)Rusch Intl.2002-12-23
MADETT (K021044)Wolfe Tory Medical, Inc.2002-09-11
RUSCH EDGAR TUBE (K021540)Rusch Intl.2002-08-01
SILICONE TRACHEAL T-TUBES (K013321)Technical Products, Inc.2002-06-04
POSITUBE (K000045)Paraproducts, Inc.2000-03-15
ILM ENDOTRACHEAL TUBE (K991580)The Laryngeal Mask Co., Ltd.2000-02-04
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY (K993786)Rusch Intl.2000-02-02
MODIFICATION TO LASER-SHIELD II (K993582)Xomed, Inc.2000-01-20
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE (K990619)Rusch Intl.1999-08-03
PARKER FLEX-TIP TRACHEAL TUBE (K984528)Parker Medical Assoc.1999-07-15
ESOPHAGEAL INTUBATION DETECTOR (K990556)Wolfe Tory Medical, Inc.1999-03-26
VENTLAB VERIFY II (K990098)Ventlab Corp.1999-02-11
AMBU TUBECHECK (K981891)Ambu, Inc.1998-07-17
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER (K971759)Green Field Medical Sourcing, Inc.1998-03-02
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM (K973191)Pulmonx1998-02-13
T-WALL UNCUFFED TRACHEAL TUBE (K970196)Vital Signs, Inc.1997-08-21
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (K965132)Mallinckrodt Medical1997-03-20
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE (K962389)Unomedical Sdn Bhd1996-11-21
ESOPHAGEAL INTUBATION DETECTOR (K962098)Kirk Specialty Systems1996-10-08
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY (K961837)Rusch Intl.1996-08-16
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY (K961840)Rusch Intl.1996-06-27
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (K955495)Rusch, Inc.1996-06-27
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE (K960795)Vygon Corp.1996-05-22
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE (K954585)Rusch Intl.1996-05-10
HEBELER SAFE-T-TUBE (K960450)Boston Medical Products, Inc.1996-04-19
TEVES ECM PLUS THERMOCOUPLE (K951768)Advanced Medical Concepts, Inc.1995-12-15
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE (K954754)Unomedical Sdn Bhd1995-12-08
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