FDA Product Code
FDA Product Code BTR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5730
510(k) Clearances — 242 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2026-09-03 | Traditional | PDF ↗ |
| K253437 | Spiro-VISTA | Spiro Robotics | 2026-06-12 | Traditional | PDF ↗ |
| K250173 | 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) | Covidien, LLC | 2025-10-06 | Traditional | PDF ↗ |
| K243785 | 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 | Covidien, LLC | 2025-09-25 | Traditional | PDF ↗ |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | 2025-08-13 | Traditional | PDF ↗ |
| K251499 | 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) | William Cook Europe Aps | 2025-06-11 | Special | PDF ↗ |
| K250243 | 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) | Flexicare Medical Limited. | 2025-05-20 | Traditional | PDF ↗ |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | 2025-04-29 | Traditional | PDF ↗ |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | 2025-02-11 | Traditional | PDF ↗ |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Covidien, LLC | 2024-05-20 | Traditional | PDF ↗ |
| K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | Covidien | 2023-08-30 | Traditional | PDF ↗ |
| K211543 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | 2022-07-21 | Traditional | PDF ↗ |
| K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2021-10-21 | Special | PDF ↗ |
| K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | 2020-11-25 | Traditional | PDF ↗ |
| K192120 | 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 | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 | Traditional | PDF ↗ |
| K190878 | 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 | Salter Labs, Inc. | 2020-01-10 | Traditional | PDF ↗ |
| K182739 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | 2019-12-11 | Special | PDF ↗ |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | 2019-12-06 | Traditional | PDF ↗ |
| K190630 | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | 2019-10-09 | Traditional | PDF ↗ |
| K190213 | Yikang Endotracheal Tube | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2019-09-06 | Traditional | PDF ↗ |
| K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | 2019-07-30 | Traditional | PDF ↗ |
| K181880 | VivaSight-SL (TVT) system | Etview , Ltd. | 2018-11-29 | Special | PDF ↗ |
| K171917 | Frova Intubating Introducer | Cook Incorporated | 2018-04-23 | Traditional | PDF ↗ |
| K172208 | NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet | Nevap, Inc. | 2018-02-16 | Traditional | PDF ↗ |
| K170234 | Endotracheal tube; Reinforced Endotracheal tube | Zhanjiang Star Enterprise Co., Ltd. | 2018-01-17 | Traditional | PDF ↗ |
| K171411 | IRRIS (Infra-Red-Red Intubation System) | A.R Guide IN Medical , Ltd. | 2018-01-12 | Traditional | PDF ↗ |
| K161813 | Frova Intubating Introducer | William Cook Europe Aps | 2017-05-19 | Traditional | PDF ↗ |
| K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017-04-07 | Traditional | PDF ↗ |
| K152438 | ETView VivaSight-SL (TVT) system | Etview , Ltd. | 2016-02-25 | Traditional | PDF ↗ |
| K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | Covidien | 2015-12-11 | Traditional | PDF ↗ |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | Teleflexmedical, Inc. | 2015-11-27 | Traditional | PDF ↗ |
| K141747 | RHINOGUARD | Davis Medical | 2015-04-20 | Traditional | PDF ↗ |
| K140228 | DISPOSABLE TRACHEAL TUBE | Suzhou Weikang Medical Apparatus Co., Ltd. | 2014-12-18 | Traditional | PDF ↗ |
| K141939 | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET | Teleflexmedical, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K132415 | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE | Teleflexmedical, Inc. | 2014-06-06 | Traditional | PDF ↗ |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | Kimberly-Clark Corp. | 2013-08-20 | Traditional | PDF ↗ |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | Kimberly-Clark Corp. | 2012-12-19 | Abbreviated | PDF ↗ |
| K111406 | BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | Traditional | PDF ↗ |
| K111401 | BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE | Hangzhou Bever Medical Devices Co., Ltd. | 2012-07-19 | Traditional | PDF ↗ |
| K121028 | ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) | Etview , Ltd. | 2012-06-21 | Traditional | PDF ↗ |
| K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | Kimberly-Clark Corporation | 2012-05-11 | Traditional | PDF ↗ |
| K110962 | AMBU ASCOPE 2 | Ambu A/S | 2011-11-18 | Traditional | PDF ↗ |
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | Well Lead Medical Co., Ltd. | 2011-08-26 | Traditional | PDF ↗ |
| K100546 | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | Parkermedicalinc | 2010-06-03 | Traditional | PDF ↗ |
| K093186 | AMBU ASCOPE AND MONITOR | Ambu A/S | 2010-04-16 | Traditional | PDF ↗ |
| K093135 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE | Venner Medical (Singapore) Pte, Ltd. | 2010-04-02 | Traditional | PDF ↗ |
| K091761 | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT | Teleflexmedical, Inc. | 2009-10-29 | Abbreviated | PDF ↗ |
| K090777 | EZC MEDICAL, LLC INTUBAIDFLEX | Ezc Medical, LLC | 2009-08-04 | Traditional | PDF ↗ |
| K083119 | PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 | Smiths Medical Asd, Inc. | 2009-06-26 | Abbreviated | PDF ↗ |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | Flexicare Medical, Ltd. | 2009-06-17 | Traditional | PDF ↗ |
| K082038 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V | Clarus Medical, LLC | 2009-04-28 | Traditional | PDF ↗ |
| K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | Covidien | 2009-04-03 | Special | PDF ↗ |
| K080105 | ENDOTRACHEAL TUBE | Chilecom Medical Devices Co., Ltd. | 2009-02-13 | Traditional | PDF ↗ |
| K080339 | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) | Medsource International, LLC | 2008-10-27 | Traditional | PDF ↗ |
| K082420 | TRACHEOSCOPIC VENTILATION TUBE (TVT) | Etview | 2008-10-08 | Special | PDF ↗ |
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | Mallinckrodt Medical | 2008-10-02 | Special | PDF ↗ |
| K081086 | 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 | Smiths Medical Asd, Inc. | 2008-08-13 | Traditional | PDF ↗ |
| K073383 | WELL LEAD REINFORCED ENDOTRACHEAL TUBE | Well Lead Medical Instruments | 2008-07-10 | Traditional | PDF ↗ |
| K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE | Kimberly-Clark Corp. | 2008-04-22 | Special | PDF ↗ |
| K080170 | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) | C.R. Bard, Inc. | 2008-03-25 | Special | PDF ↗ |
| K071365 | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE | C.R. Bard, Inc. | 2007-11-06 | Traditional | PDF ↗ |
| K060094 | ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES | Arcadia Medical Corporation | 2006-05-08 | Traditional | PDF ↗ |
| K051993 | LMA FASTRACH ETT SINGLE USE | The Laryngeal Mask Co., Ltd. | 2005-12-13 | Traditional | PDF ↗ |
| K052233 | TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM | Etview , Ltd. | 2005-12-13 | Traditional | PDF ↗ |
| K050785 | AMSINO ENDOTRACHEAL TUBE | Amsino International, Inc. | 2005-07-15 | Traditional | PDF ↗ |
| K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES | Vitaid, Ltd. | 2005-06-30 | Traditional | PDF ↗ |
| K041311 | TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) | Tiger Medical Products, Ltd. | 2005-03-18 | Abbreviated | PDF ↗ |
| K042683 | WELL LEAD ENDOTRACHEAL TUBE | Well Lead Medical Instruments | 2005-02-18 | Traditional | PDF ↗ |
| K041917 | PLASIATEK ACTUATOR | Plasiatek, LLC | 2005-01-07 | Traditional | PDF ↗ |
| K043205 | RUSCH EASY TUBE | Teleflex Medical | 2005-01-07 | Traditional | PDF ↗ |
| K040657 | BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 | Vygon SA | 2004-06-10 | Traditional | PDF ↗ |
| K031794 | ENDOFLEX TRACHEAL TUBE | Merlyn Associates, Inc. | 2004-03-12 | Traditional | PDF ↗ |
| K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) | Portex , Ltd. | 2004-01-26 | Traditional | PDF ↗ |
| K030792 | BARD ENDOTRACHEAL TUBE, CUFFED | C.R. Bard, Inc. | 2003-11-14 | Traditional | PDF ↗ |
| K023964 | RUSCH MICROLARYNGEAL TUBE | Rusch Intl. | 2002-12-23 | Traditional | PDF ↗ |
| K021044 | MADETT | Wolfe Tory Medical, Inc. | 2002-09-11 | Traditional | PDF ↗ |
| K021540 | RUSCH EDGAR TUBE | Rusch Intl. | 2002-08-01 | Traditional | PDF ↗ |
| K013321 | SILICONE TRACHEAL T-TUBES | Technical Products, Inc. | 2002-06-04 | Traditional | PDF ↗ |
| K000045 | POSITUBE | Paraproducts, Inc. | 2000-03-15 | Traditional | PDF ↗ |
| K991580 | ILM ENDOTRACHEAL TUBE | The Laryngeal Mask Co., Ltd. | 2000-02-04 | Traditional | PDF ↗ |
| K993786 | RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY | Rusch Intl. | 2000-02-02 | Traditional | PDF ↗ |
| K993582 | MODIFICATION TO LASER-SHIELD II | Xomed, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE | Rusch Intl. | 1999-08-03 | Traditional | PDF ↗ |
| K984528 | PARKER FLEX-TIP TRACHEAL TUBE | Parker Medical Assoc. | 1999-07-15 | Traditional | PDF ↗ |
| K990556 | ESOPHAGEAL INTUBATION DETECTOR | Wolfe Tory Medical, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K990098 | VENTLAB VERIFY II | Ventlab Corp. | 1999-02-11 | Traditional | PDF ↗ |
| K981891 | AMBU TUBECHECK | Ambu, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K971759 | MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER | Green Field Medical Sourcing, Inc. | 1998-03-02 | Traditional | PDF ↗ |
| K973191 | THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM | Pulmonx | 1998-02-13 | Traditional | PDF ↗ |
| K970196 | T-WALL UNCUFFED TRACHEAL TUBE | Vital Signs, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | Mallinckrodt Medical | 1997-03-20 | Traditional | PDF ↗ |
| K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | Unomedical Sdn Bhd | 1996-11-21 | Traditional | PDF ↗ |
| K962098 | ESOPHAGEAL INTUBATION DETECTOR | Kirk Specialty Systems | 1996-10-08 | Traditional | PDF ↗ |
| K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY | Rusch Intl. | 1996-08-16 | Traditional | PDF ↗ |
| K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | Rusch, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K961840 | RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY | Rusch Intl. | 1996-06-27 | Traditional | PDF ↗ |
| K960795 | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE | Vygon Corp. | 1996-05-22 | Traditional | PDF ↗ |
| K954585 | RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE | Rusch Intl. | 1996-05-10 | Traditional | PDF ↗ |
| K960450 | HEBELER SAFE-T-TUBE | Boston Medical Products, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K951768 | TEVES ECM PLUS THERMOCOUPLE | Advanced Medical Concepts, Inc. | 1995-12-15 | Traditional | PDF ↗ |
Product code BTR · Class II · Anesthesiology. Data: openFDA.