ClearanceBrief
Panels › Anesthesiology › Product code BTR · Class 2

Tube, Tracheal (W/Wo Connector)

Regulation 868.5730

2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
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Top companies in BTR

Company510(k)sRecalls
Teleflex Incorporated1127
Teleflex Medical248
Smiths Medical017
Smiths Medical Asd, Inc.210
Sheridan Catheter Corp.110
Mallinckrodt Critical Care100
Rusch, Inc.100
Bivona Medical Technologies80
Covidien61
Polamedco, Inc.70
Decided510(k)Device and applicantCode
Sep 3, 2026K251794Tenax® Laser Resistant Endotracheal Tube
Bryan Medical, Inc.
BTR
Jun 12, 2026K253437Spiro-VISTA
Spiro Robotics
BTR
Oct 6, 2025K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-X
Covidien, LLC
BTR
Sep 25, 2025K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Re
Covidien, LLC
BTR
Aug 13, 2025K243579AeroJet Ventilation Catheter
Pipeline Medical Products, LLC
BTR
Jun 11, 2025K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introd
William Cook Europe Aps, DK
BTR
May 20, 2025K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Rein
Flexicare Medical Limited., GB
BTR
Apr 29, 2025K242495LMA Fastrach ETT SU
Teleflex Medical
BTR
Feb 11, 2025K241451Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear P
Teleflex Incorporated
BTR
May 20, 2024K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465
Covidien, LLC
BTR
Aug 30, 2023K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150
Covidien
BTR
Jul 21, 2022K211543Wei Nasal Jet Tube
Well Lead Medical Co., Ltd., CN
BTR
Oct 21, 2021K213028Tenax Laser Resistant Endotracheal Tube
Bryan Medical, Inc.
BTR
Nov 25, 2020K200761Tenax Laser Resistant Endotracheal Tube
Bryan Medical, Inc.
BTR
Feb 14, 2020K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotrach
Venner Medical (Singapore) Pte, Ltd., SG
BTR
Jan 10, 2020K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endot
Salter Labs, Inc.
BTR
Dec 11, 2019K182739Endotracheal Tube with Evacuation Lumen
Well Lead Medical Co., Ltd., CN
BTR
Dec 6, 2019K192324Sheridan Spiral-Flex Endotracheal Tubes
Teleflexmedical, Inc.
BTR
Oct 9, 2019K190630SolidAIRity III Airway Stabilization System
Securisyn Medical, LLC
BTR
Sep 6, 2019K190213Yikang Endotracheal Tube
Jiangxi Yikang Medical Instrument Group Co., Ltd., CN
BTR
Jul 30, 2019K190274Endotracheal Tube
Tianjin Medis Medical Device Co., Ltd., CN
BTR
Nov 29, 2018K181880VivaSight-SL (TVT) system
Etview , Ltd., IL
BTR
Apr 23, 2018K171917Frova Intubating Introducer
Cook Incorporated
BTR
Feb 16, 2018K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
Nevap, Inc.
BTR
Jan 17, 2018K170234Endotracheal tube; Reinforced Endotracheal tube
Zhanjiang Star Enterprise Co., Ltd., TW
BTR
Jan 12, 2018K171411IRRIS (Infra-Red-Red Intubation System)
A.R Guide IN Medical , Ltd., IL
BTR
May 19, 2017K161813Frova Intubating Introducer
William Cook Europe Aps, DK
BTR
Apr 7, 2017K160694Disposable Endotracheal tube, sterile, AccuCuff
Tianjin Medis Medical Device Co., Ltd., CN
BTR
Feb 25, 2016K152438ETView VivaSight-SL (TVT) system
Etview , Ltd., IL
BTR
Dec 11, 2015K151381Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
Covidien
BTR
Nov 27, 2015K150603Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
Teleflexmedical, Inc.
BTR
Apr 20, 2015K141747RHINOGUARD
Davis Medical
BTR
Dec 18, 2014K140228DISPOSABLE TRACHEAL TUBE
Suzhou Weikang Medical Apparatus Co., Ltd., CN
BTR
Nov 24, 2014K141939TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
Teleflexmedical, Inc.
BTR
Jun 6, 2014K132415RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
Teleflexmedical, Inc.
BTR
Aug 20, 2013K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
Kimberly-Clark Corp.
BTR
Dec 19, 2012K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
Kimberly-Clark Corp.
BTR
Jul 19, 2012K111406BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
Hangzhou Bever Medical Devices Co., Ltd., CN
BTR
Jul 19, 2012K111401BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
Hangzhou Bever Medical Devices Co., Ltd., CN
BTR
Jun 21, 2012K121028ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
Etview , Ltd., IL
BTR
May 11, 2012K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
Kimberly-Clark Corporation
BTR
Nov 18, 2011K110962AMBU ASCOPE 2
Ambu A/S
BTR
Aug 26, 2011K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
Well Lead Medical Co., Ltd.
BTR
Jun 3, 2010K100546PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
Parkermedicalinc
BTR
Apr 16, 2010K093186AMBU ASCOPE AND MONITOR
Ambu A/S
BTR
Apr 2, 2010K093135VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
Venner Medical (Singapore) Pte, Ltd.
BTR
Oct 29, 2009K091761TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
Teleflexmedical, Inc.
BTR
Aug 4, 2009K090777EZC MEDICAL, LLC INTUBAIDFLEX
Ezc Medical, LLC
BTR
Jun 26, 2009K083119PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
Smiths Medical Asd, Inc., GB
BTR
Jun 17, 2009K091591FLEXICARE MEDICAL ENDOTRACHEAL TUBES
Flexicare Medical, Ltd., GB
BTR

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