FDA 510(k) Applications for Medical Device Product Code "BTR"
(Tube, Tracheal (W/Wo Connector))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K171411 | A.R Guide In Medical Ltd. | IRRIS (Infra-Red-Red Intubation System) | 01/12/2018 |
| K110962 | AMBU A/S | AMBU ASCOPE 2 | 11/18/2011 |
| K093186 | AMBU A/S | AMBU ASCOPE AND MONITOR | 04/16/2010 |
| K981891 | AMBU, INC. | AMBU TUBECHECK | 07/17/1998 |
| K050785 | AMSINO INTERNATIONAL, INC. | AMSINO ENDOTRACHEAL TUBE | 07/15/2005 |
| K060094 | ARCADIA MEDICAL CORPORATION | ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES | 05/08/2006 |
| K960450 | BOSTON MEDICAL PRODUCTS, INC. | HEBELER SAFE-T-TUBE | 04/19/1996 |
| K213028 | Bryan Medical , Inc. | Tenax Laser Resistant Endotracheal Tube | 10/21/2021 |
| K200761 | Bryan Medical, Inc. | Tenax Laser Resistant Endotracheal Tube | 11/25/2020 |
| K071365 | C.R. BARD, INC. | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE | 11/06/2007 |
| K080170 | C.R. BARD, INC. | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) | 03/25/2008 |
| K030792 | C.R. BARD, INC. | BARD ENDOTRACHEAL TUBE, CUFFED | 11/14/2003 |
| K080105 | CHILECOM MEDICAL DEVICES CO., LTD. | ENDOTRACHEAL TUBE | 02/13/2009 |
| K082038 | CLARUS MEDICAL, LLC. | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V | 04/28/2009 |
| K171917 | Cook Incorporated | Frova Intubating Introducer | 04/23/2018 |
| K151381 | Covidien | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | 12/11/2015 |
| K223130 | Covidien | ShileyÖ Pediatric Oral/Nasal Endotracheal Tube with TaperGuardÖ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | 08/30/2023 |
| K090352 | COVIDIEN | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | 04/03/2009 |
| K141747 | DAVIS MEDICAL | RHINOGUARD | 04/20/2015 |
| K082420 | ETVIEW | TRACHEOSCOPIC VENTILATION TUBE (TVT) | 10/08/2008 |
| K121028 | ETVIEW LTD. | ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) | 06/21/2012 |
| K152438 | ETVIEW LTD. | ETView VivaSight-SL (TVT) system | 02/25/2016 |
| K052233 | ETVIEW LTD. | TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM | 12/13/2005 |
| K181880 | ETView Ltd. | VivaSight-SL (TVT) system | 11/29/2018 |
| K090777 | EZC MEDICAL, LLC | EZC MEDICAL, LLC INTUBAIDFLEX | 08/04/2009 |
| K091591 | FLEXICARE MEDICAL LTD. | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | 06/17/2009 |
| K971759 | GREEN FIELD MEDICAL SOURCING, INC. | MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER | 03/02/1998 |
| K111401 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE | 07/19/2012 |
| K111406 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) | 07/19/2012 |
| K190213 | Jiangxi Yikang Medical Instrument Group Co., Ltd | Yikang Endotracheal Tube | 09/06/2019 |
| K120985 | KIMBERLY-CLARK CORP. | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | 12/19/2012 |
| K131254 | KIMBERLY-CLARK CORP. | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | 08/20/2013 |
| K080821 | KIMBERLY-CLARK CORP. | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE | 04/22/2008 |
| K113333 | KIMBERLY-CLARK CORPORATION | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | 05/11/2012 |
| K962098 | KIRK SPECIALTY SYSTEMS | ESOPHAGEAL INTUBATION DETECTOR | 10/08/1996 |
| K965132 | MALLINCKRODT MEDICAL | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | 03/20/1997 |
| K082520 | MALLINCKRODT MEDICAL | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | 10/02/2008 |
| K080339 | MEDSOURCE INTERNATIONAL, LLC. | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) | 10/27/2008 |
| K031794 | MERLYN ASSOCIATES INC. | ENDOFLEX TRACHEAL TUBE | 03/12/2004 |
| K172208 | NeVap, Inc. | NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet | 02/16/2018 |
| K000045 | PARAPRODUCTS, INC. | POSITUBE | 03/15/2000 |
| K984528 | PARKER MEDICAL ASSOC. | PARKER FLEX-TIP TRACHEAL TUBE | 07/15/1999 |
| K100546 | PARKERMEDICALINC | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | 06/03/2010 |
| K041917 | PLASIATEK, LLC | PLASIATEK ACTUATOR | 01/07/2005 |
| K032112 | PORTEX LTD. | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) | 01/26/2004 |
| K973191 | PULMONX | THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM | 02/13/1998 |
| K021540 | RUSCH INTL. | RUSCH EDGAR TUBE | 08/01/2002 |
| K023964 | RUSCH INTL. | RUSCH MICROLARYNGEAL TUBE | 12/23/2002 |
| K993786 | RUSCH INTL. | RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY | 02/02/2000 |
| K961840 | RUSCH INTL. | RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY | 06/27/1996 |
| K954585 | RUSCH INTL. | RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE | 05/10/1996 |
| K990619 | RUSCH INTL. | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE | 08/03/1999 |
| K961837 | RUSCH INTL. | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY | 08/16/1996 |
| K955495 | RUSCH, INC. | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | 06/27/1996 |
| K190878 | Salter Labs, Inc. | 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 | 01/10/2020 |
| K190630 | Securisyn Medical, LLC | SolidAIRity III Airway Stabilization System | 10/09/2019 |
| K081086 | SMITHS MEDICAL ASD, INC. | 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 | 08/13/2008 |
| K083119 | SMITHS MEDICAL ASD, INC. | PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 | 06/26/2009 |
| K140228 | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD | DISPOSABLE TRACHEAL TUBE | 12/18/2014 |
| K013321 | TECHNICAL PRODUCTS, INC. | SILICONE TRACHEAL T-TUBES | 06/04/2002 |
| K043205 | TELEFLEX MEDICAL | RUSCH EASY TUBE | 01/07/2005 |
| K150603 | Teleflex Medical, Inc. | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | 11/27/2015 |
| K132415 | Teleflex Medical, Inc. | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE | 06/06/2014 |
| K141939 | Teleflex Medical, Inc. | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET | 11/24/2014 |
| K091761 | Teleflex Medical, Inc. | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT | 10/29/2009 |
| K192324 | TeleflexMedical, Inc | Sheridan Spiral-Flex Endotracheal Tubes | 12/06/2019 |
| K991580 | THE LARYNGEAL MASK CO.,LTD. | ILM ENDOTRACHEAL TUBE | 02/04/2000 |
| K051993 | THE LARYNGEAL MASK CO.,LTD. | LMA FASTRACH ETT SINGLE USE | 12/13/2005 |
| K160694 | TIANJIN MEDIS MEDICAL DEVICE CO., LTD. | Disposable Endotracheal tube, sterile, AccuCuff | 04/07/2017 |
| K190274 | Tianjin Medis Medical Device Co., Ltd. | Endotracheal Tube | 07/30/2019 |
| K041311 | TIGER MEDICAL PRODUCTS LTD | TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) | 03/18/2005 |
| K962389 | UNOMEDICAL SDN BHD | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | 11/21/1996 |
| K093135 | VENNER MEDICAL (SINGAPORE) PTE LTD | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE | 04/02/2010 |
| K192120 | Venner Medical (Singapore) Pte Ltd | Venner PneuXÖ ETT (Endotracheal Tube) 6 mm, Venner PneuXÖ ETT (Endotracheal Tube) 7 mm, Venner PneuXÖ ETT (Endotracheal Tube) 8 mm, Venner PneuXÖ ETT (Endotracheal Tube) 9 mm | 02/14/2020 |
| K990098 | VENTLAB CORP. | VENTLAB VERIFY II | 02/11/1999 |
| K050803 | VITAID, LTD. | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES | 06/30/2005 |
| K970196 | VITAL SIGNS, INC. | T-WALL UNCUFFED TRACHEAL TUBE | 08/21/1997 |
| K960795 | VYGON CORP. | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE | 05/22/1996 |
| K040657 | VYGON S A | BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 | 06/10/2004 |
| K110269 | WELL LEAD MEDICAL CO. LTD | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | 08/26/2011 |
| K182739 | WELL LEAD MEDICAL CO., LTD. | Endotracheal Tube with Evacuation Lumen | 12/11/2019 |
| K211543 | Well Lead Medical Co., LTD. | Wei Nasal Jet Tube | 07/21/2022 |
| K042683 | WELL LEAD MEDICAL INSTRUMENTS | WELL LEAD ENDOTRACHEAL TUBE | 02/18/2005 |
| K073383 | WELL LEAD MEDICAL INSTRUMENTS | WELL LEAD REINFORCED ENDOTRACHEAL TUBE | 07/10/2008 |
| K161813 | WILLIAM COOK EUROPE APS | Frova Intubating Introducer | 05/19/2017 |
| K990556 | WOLFE TORY MEDICAL, INC. | ESOPHAGEAL INTUBATION DETECTOR | 03/26/1999 |
| K021044 | WOLFE TORY MEDICAL, INC. | MADETT | 09/11/2002 |
| K993582 | XOMED, INC. | MODIFICATION TO LASER-SHIELD II | 01/20/2000 |
| K170234 | Zhanjiang Star Enterprise Co., Ltd | Endotracheal tube; Reinforced Endotracheal tube | 01/17/2018 |
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