Product Code: BTR FDA class 2 21 CFR 868.5730

Tube, Tracheal (W/Wo Connector)

Anesthesiology

The Tube, Tracheal (W/Wo Connector) is a flexible tube inserted through the mouth or nose and advanced into the trachea to secure the airway and enable mechanical ventilation during surgery or critical care. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTR, regulated under 21 CFR 868.5730 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

241

FEI Numbers

132

Registration Numbers

132

Unique Applicants

125

Years Active

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Basic Information

Product Code: BTR
Device Class: FDA class 2
Regulation Number: 868.5730
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 241 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253437	Spiro-VISTA	Jun 12, 2026	Substantially Equivalent	Spiro Robotics
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)	Oct 06, 2025	Substantially Equivalent	Covidien, LLC
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	Sep 25, 2025	Substantially Equivalent	Covidien, LLC
K243579	AeroJet Ventilation Catheter	Aug 13, 2025	Substantially Equivalent	Pipeline Medical Products, LLC
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)	Jun 11, 2025	Substantially Equivalent	William Cook Europe Aps
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)	May 20, 2025	Substantially Equivalent	Flexicare Medical Limited.
K242495	LMA Fastrach ETT SU	Apr 29, 2025	Substantially Equivalent	Teleflex Medical
K241451	Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)	Feb 11, 2025	Substantially Equivalent	Teleflex Incorporated
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)	May 20, 2024	Substantially Equivalent	Covidien, LLC
K223130	Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)	Aug 30, 2023	Substantially Equivalent	Covidien
K211543	Wei Nasal Jet Tube	Jul 21, 2022	Substantially Equivalent	Well Lead Medical Co., Ltd.
K213028	Tenax Laser Resistant Endotracheal Tube	Oct 21, 2021	Substantially Equivalent	Bryan Medical, Inc.
K200761	Tenax Laser Resistant Endotracheal Tube	Nov 25, 2020	Substantially Equivalent	Bryan Medical, Inc.
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	Feb 14, 2020	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
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	Jan 10, 2020	Substantially Equivalent	Salter Labs, Inc.
K182739	Endotracheal Tube with Evacuation Lumen	Dec 11, 2019	Substantially Equivalent	Well Lead Medical Co., Ltd.
K192324	Sheridan Spiral-Flex Endotracheal Tubes	Dec 06, 2019	Substantially Equivalent	Teleflexmedical, Inc.
K190630	SolidAIRity III Airway Stabilization System	Oct 09, 2019	Substantially Equivalent	Securisyn Medical, LLC
K190213	Yikang Endotracheal Tube	Sep 06, 2019	Substantially Equivalent	Jiangxi Yikang Medical Instrument Group Co., Ltd.
K190274	Endotracheal Tube	Jul 30, 2019	Substantially Equivalent	Tianjin Medis Medical Device Co., Ltd.
K181880	VivaSight-SL (TVT) system	Nov 29, 2018	Substantially Equivalent	Etview , Ltd.
K171917	Frova Intubating Introducer	Apr 23, 2018	Substantially Equivalent	Cook Incorporated
K172208	NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet	Feb 16, 2018	Substantially Equivalent	Nevap, Inc.
K170234	Endotracheal tube; Reinforced Endotracheal tube	Jan 17, 2018	Substantially Equivalent	Zhanjiang Star Enterprise Co., Ltd.
K171411	IRRIS (Infra-Red-Red Intubation System)	Jan 12, 2018	Substantially Equivalent	A.R Guide IN Medical , Ltd.
K161813	Frova Intubating Introducer	May 19, 2017	Substantially Equivalent	William Cook Europe Aps
K160694	Disposable Endotracheal tube, sterile, AccuCuff	Apr 07, 2017	Substantially Equivalent	Tianjin Medis Medical Device Co., Ltd.
K152438	ETView VivaSight-SL (TVT) system	Feb 25, 2016	Substantially Equivalent	Etview , Ltd.
K151381	Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye	Dec 11, 2015	Substantially Equivalent	Covidien
K150603	Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube	Nov 27, 2015	Substantially Equivalent	Teleflexmedical, Inc.
K141747	RHINOGUARD	Apr 20, 2015	Substantially Equivalent	Davis Medical
K140228	DISPOSABLE TRACHEAL TUBE	Dec 18, 2014	Substantially Equivalent	Suzhou Weikang Medical Apparatus Co., Ltd.
K141939	TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET	Nov 24, 2014	Substantially Equivalent	Teleflexmedical, Inc.
K132415	RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE	Jun 06, 2014	Substantially Equivalent	Teleflexmedical, Inc.
K131254	KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE	Aug 20, 2013	Substantially Equivalent	Kimberly-Clark Corp.
K120985	KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING	Dec 19, 2012	Substantially Equivalent	Kimberly-Clark Corp.
K111406	BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)	Jul 19, 2012	Substantially Equivalent	Hangzhou Bever Medical Devices Co., Ltd.
K111401	BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE	Jul 19, 2012	Substantially Equivalent	Hangzhou Bever Medical Devices Co., Ltd.
K121028	ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))	Jun 21, 2012	Substantially Equivalent	Etview , Ltd.
K113333	KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS	May 11, 2012	Substantially Equivalent	Kimberly-Clark Corporation
K110962	AMBU ASCOPE 2	Nov 18, 2011	Substantially Equivalent	Ambu A/S
K110269	WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL	Aug 26, 2011	Substantially Equivalent	Well Lead Medical Co., Ltd.
K100546	PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE	Jun 03, 2010	Substantially Equivalent	Parkermedicalinc
K093186	AMBU ASCOPE AND MONITOR	Apr 16, 2010	Substantially Equivalent	Ambu A/S
K093135	VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE	Apr 02, 2010	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
K091761	TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT	Oct 29, 2009	Substantially Equivalent	Teleflexmedical, Inc.
K090777	EZC MEDICAL, LLC INTUBAIDFLEX	Aug 04, 2009	Substantially Equivalent	Ezc Medical, LLC
K083119	PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5	Jun 26, 2009	Substantially Equivalent	Smiths Medical Asd, Inc.
K091591	FLEXICARE MEDICAL ENDOTRACHEAL TUBES	Jun 17, 2009	Substantially Equivalent	Flexicare Medical, Ltd.
K082038	CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V	Apr 28, 2009	Substantially Equivalent	Clarus Medical, LLC
K090352	TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES	Apr 03, 2009	Substantially Equivalent	Covidien
K080105	ENDOTRACHEAL TUBE	Feb 13, 2009	Substantially Equivalent	Chilecom Medical Devices Co., Ltd.
K080339	MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)	Oct 27, 2008	Substantially Equivalent	Medsource International, LLC
K082420	TRACHEOSCOPIC VENTILATION TUBE (TVT)	Oct 08, 2008	Substantially Equivalent	Etview
K082520	SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES	Oct 02, 2008	Substantially Equivalent	Mallinckrodt Medical
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	Aug 13, 2008	Substantially Equivalent	Smiths Medical Asd, Inc.
K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	Jul 10, 2008	Substantially Equivalent	Well Lead Medical Instruments
K080821	MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE	Apr 22, 2008	Substantially Equivalent	Kimberly-Clark Corp.
K080170	AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)	Mar 25, 2008	Substantially Equivalent	C.R. Bard, Inc.
K071365	AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE	Nov 06, 2007	Substantially Equivalent	C.R. Bard, Inc.
K060094	ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES	May 08, 2006	Substantially Equivalent	Arcadia Medical Corporation
K052233	TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM	Dec 13, 2005	Substantially Equivalent	Etview , Ltd.
K051993	LMA FASTRACH ETT SINGLE USE	Dec 13, 2005	Substantially Equivalent	The Laryngeal Mask Co., Ltd.
K050785	AMSINO ENDOTRACHEAL TUBE	Jul 15, 2005	Substantially Equivalent	Amsino International, Inc.
K050803	PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES	Jun 30, 2005	Substantially Equivalent	Vitaid, Ltd.
K041311	TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)	Mar 18, 2005	Substantially Equivalent	Tiger Medical Products, Ltd.
K042683	WELL LEAD ENDOTRACHEAL TUBE	Feb 18, 2005	Substantially Equivalent	Well Lead Medical Instruments
K043205	RUSCH EASY TUBE	Jan 07, 2005	Substantially Equivalent	Teleflex Medical
K041917	PLASIATEK ACTUATOR	Jan 07, 2005	Substantially Equivalent	Plasiatek, LLC
K040657	BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80	Jun 10, 2004	Substantially Equivalent	Vygon SA
K031794	ENDOFLEX TRACHEAL TUBE	Mar 12, 2004	Substantially Equivalent	Merlyn Associates, Inc.
K032112	P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)	Jan 26, 2004	Substantially Equivalent	Portex , Ltd.
K030792	BARD ENDOTRACHEAL TUBE, CUFFED	Nov 14, 2003	Substantially Equivalent	C.R. Bard, Inc.
K023964	RUSCH MICROLARYNGEAL TUBE	Dec 23, 2002	Substantially Equivalent	Rusch Intl.
K021044	MADETT	Sep 11, 2002	Substantially Equivalent	Wolfe Tory Medical, Inc.
K021540	RUSCH EDGAR TUBE	Aug 01, 2002	Substantially Equivalent	Rusch Intl.
K013321	SILICONE TRACHEAL T-TUBES	Jun 04, 2002	Substantially Equivalent	Technical Products, Inc.
K000045	POSITUBE	Mar 15, 2000	Substantially Equivalent	Paraproducts, Inc.
K991580	ILM ENDOTRACHEAL TUBE	Feb 04, 2000	Substantially Equivalent	The Laryngeal Mask Co., Ltd.
K993786	RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY	Feb 02, 2000	Substantially Equivalent	Rusch Intl.
K993582	MODIFICATION TO LASER-SHIELD II	Jan 20, 2000	Substantially Equivalent	Xomed, Inc.
K990619	RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE	Aug 03, 1999	Substantially Equivalent	Rusch Intl.
K984528	PARKER FLEX-TIP TRACHEAL TUBE	Jul 15, 1999	Substantially Equivalent	Parker Medical Assoc.
K990556	ESOPHAGEAL INTUBATION DETECTOR	Mar 26, 1999	Substantially Equivalent	Wolfe Tory Medical, Inc.
K990098	VENTLAB VERIFY II	Feb 11, 1999	Substantially Equivalent	Ventlab Corp.
K981891	AMBU TUBECHECK	Jul 17, 1998	Substantially Equivalent	Ambu, Inc.
K971759	MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER	Mar 02, 1998	Substantially Equivalent	Green Field Medical Sourcing, Inc.
K973191	THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM	Feb 13, 1998	Substantially Equivalent	Pulmonx
K970196	T-WALL UNCUFFED TRACHEAL TUBE	Aug 21, 1997	Substantially Equivalent	Vital Signs, Inc.
K965132	HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES	Mar 20, 1997	Substantially Equivalent	Mallinckrodt Medical
K962389	EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE	Nov 21, 1996	Substantially Equivalent	Unomedical Sdn Bhd
K962098	ESOPHAGEAL INTUBATION DETECTOR	Oct 08, 1996	Substantially Equivalent	Kirk Specialty Systems
K961837	RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY	Aug 16, 1996	Substantially Equivalent	Rusch Intl.
K961840	RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY	Jun 27, 1996	Substantially Equivalent	Rusch Intl.
K955495	RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE	Jun 27, 1996	Substantially Equivalent	Rusch, Inc.
K960795	VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE	May 22, 1996	Substantially Equivalent	Vygon Corp.
K954585	RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE	May 10, 1996	Substantially Equivalent	Rusch Intl.
K960450	HEBELER SAFE-T-TUBE	Apr 19, 1996	Substantially Equivalent	Boston Medical Products, Inc.
K951768	TEVES ECM PLUS THERMOCOUPLE	Dec 15, 1995	Substantially Equivalent	Advanced Medical Concepts, Inc.
K954754	WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE	Dec 08, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K954753	PEDIATRIC SILICONE ENDOTRACHEAL TUBE	Dec 08, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K954751	SILICONE ENDOTRACHEAL TUBE	Dec 08, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K954750	PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE	Dec 08, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K953368	LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES	Sep 18, 1995	Substantially Equivalent	Karl Storz Endoskop GmbH
K935842	RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE	May 23, 1995	Substantially Equivalent	Rusch, Inc.
K952013	PRIMA GUEDEL AIRWAYS	May 22, 1995	Substantially Equivalent	Prima, Inc.
K951697	PEDIATRIC ENDOTRACHEAL TUBE	May 22, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K951696	ENDOTRACHEAL TUBE	May 22, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K924997	EDD	Mar 28, 1995	Substantially Equivalent	Arc Medical, Inc.
K945816	QUICK-LOCK	Jan 13, 1995	Substantially Equivalent	B&B Medical Technologies, Inc.
K945455	GENERAL ANESTHESIA SYSTEM	Dec 23, 1994	Unknown	Vital Signs, Inc.
K945745	ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)	Dec 07, 1994	Substantially Equivalent	Wolfe Tory Medical, Inc.
K944324	SURE-LOCK VENTILATOR TUBING HOLDER	Nov 04, 1994	Substantially Equivalent	B&B Medical Technologies, Inc.
K942628	ESOPHAGEAL INTUBATION DETECTOR BULB	Aug 18, 1994	Substantially Equivalent	Wolfe Tory Medical, Inc.
K940041	COLIBRI	Jul 27, 1994	Substantially Equivalent	Icor AB
K941969	ENDOPLUS	Jun 22, 1994	Substantially Equivalent	Wembley Rubber Products (M) Sdn Bhd
K941246	RAE II TRACHEAL TUBE	Apr 11, 1994	Substantially Equivalent	Mallinckrodt Medical
K934465	DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE	Jan 14, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K932647	WIRE REINFORCED ENDOTRACHEAL TUBE	Nov 02, 1993	Substantially Equivalent	Vitaid, Ltd.
K934117	STABILTUBE	Oct 25, 1993	Substantially Equivalent	Garrett Medical Products
K933398	BIVONA ILLUMINATED ENDOTRACHEAL TUBE	Oct 06, 1993	Substantially Equivalent	Bivona Medical Technologies
K925508	RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP	Sep 02, 1993	Substantially Equivalent	Rusch, Inc.
K925507	RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP	Sep 02, 1993	Substantially Equivalent	Rusch, Inc.
K925505	RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE	Sep 02, 1993	Substantially Equivalent	Rusch, Inc.
K931749	BIVONA(R) ICU ENDOTRACHEAL TUBE	Aug 10, 1993	Substantially Equivalent	Bivona Medical Technologies
K930741	ESOPHAGEAL INTUBATION DETECTOR	Aug 07, 1993	Substantially Equivalent	Wolfe-Carney Medical
K925506	RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE	Aug 02, 1993	Substantially Equivalent	Rusch, Inc.
K932711	PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS	Jul 23, 1993	Substantially Equivalent	Precision Med Products, Ltd.
K932561	GUEDEL AIRWAYS	Jul 22, 1993	Substantially Equivalent	Life Shield Healthcare Products, Inc.
K932280	RAE(R) II TRACHEAL TUBE	Jul 08, 1993	Substantially Equivalent	Mallinckrodt Medical
K931164	RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY	Jun 23, 1993	Substantially Equivalent	Rusch, Inc.
K931163	RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE	Jun 23, 1993	Substantially Equivalent	Rusch, Inc.
K931166	RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY	Jun 22, 1993	Substantially Equivalent	Rusch, Inc.
K931165	RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE	Jun 22, 1993	Substantially Equivalent	Rusch, Inc.
K931735	BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE	May 18, 1993	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K922894	LAZER-TRACH TRACHEAL TUBE	May 07, 1993	Substantially Equivalent	Sheridan Catheter Corp.
K925781	DISPOSABLE CUFFED ENDOTRACHEAL TUBE	Apr 19, 1993	Substantially Equivalent	Coast Medical Corp.
K922880	XOMED TREACE JET VENTILATION TUBE	Apr 15, 1993	Substantially Equivalent	Xomed-Treace, Inc.
K926498	ENDOGRIP	Apr 07, 1993	Substantially Equivalent	Biomedix, Inc.
K930114	TRACHEOSTOMY T-TUBE	Mar 19, 1993	Substantially Equivalent	Invotec International, Inc.
K923591	PALA-NATE	Mar 16, 1993	Substantially Equivalent	Gesco Intl., Inc.
K930179	TRACHEAL TUBE FIXATION DEVICE	Mar 03, 1993	Substantially Equivalent	Garrett Medical Products
K925855	DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE	Feb 18, 1993	Substantially Equivalent	Coast Medical Corp.
K930150	SAFE-T-TUBE RADIOPAQUE	Feb 12, 1993	Substantially Equivalent	Boston Medical Products, Inc.
K914370	MECONIUM SUCTION DEVICE (MSD)	Jan 06, 1993	Substantially Equivalent	Vital Signs, Inc.
K921077	DISPOSABLE INTUBATION KITS	Aug 25, 1992	Substantially Equivalent	Coast Medical Corp.
K910463	MEROCEL(R) LASER-GUARD(TM)	Apr 06, 1992	Substantially Equivalent	Merocel Corp.
K915277	ENDOTRACHEAL CPAP SET	Mar 20, 1992	Substantially Equivalent	Vital Signs, Inc.
K920900	POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES	Mar 18, 1992	Substantially Equivalent	Polamedco, Inc.
K915799	BIVONA SLEEP APNEA TUBE	Feb 03, 1992	Substantially Equivalent	Bivona Medical Technologies
K912290	HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))	Aug 26, 1991	Substantially Equivalent	Boston Medical Products, Inc.
K902193	KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP	Mar 15, 1991	Substantially Equivalent	Kevtek Medical Products, Inc.
K903876	MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)	Feb 04, 1991	Substantially Equivalent	Boston Medical Products, Inc.
K900457	CUFFED LINDER NASOTRACHEAL AIRWAY	Apr 16, 1990	Substantially Equivalent	Polamedco, Inc.
K896181	APT TRACHEA TUBES	Jan 09, 1990	Substantially Equivalent	Advanced Pulmonary Technologies, Inc.
K893609	TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)	Oct 30, 1989	Substantially Equivalent	Leonides Y. Teves, M.D., P.A.
K895132	CONNELL-STEPHENS ENDO ANESS TUBE	Oct 13, 1989	Substantially Equivalent	The Traumafuse Co.
K894669	LASER SHIELDING TUBE	Oct 13, 1989	Substantially Equivalent	Vitaid, Ltd.
K892432	KENDALL CURITY ENDOTRACHEAL TUBES	Jun 12, 1989	Substantially Equivalent	The Kendal Co.
K883096	TRACHEAL TUBE LASER SHIELD KIT	Sep 08, 1988	Substantially Equivalent	Americal Corp.
K881496	LINDER NASOTRACHEAL AIRWAY	May 31, 1988	Substantially Equivalent	Polamedco, Inc.
K881313	IQK-200	May 19, 1988	Substantially Equivalent	Medical Repackers Co.
K880487	NEOTECH MECONIUM ASPIRATOR (STERILE)	May 06, 1988	Substantially Equivalent	Neotech Products, Inc.
K880960	NDYAG LASER TRACHEAL TUBE	Apr 29, 1988	Substantially Equivalent	Sheridan Catheter Corp.
K874679	TRACHEAL TUBE LASER SHIELD KIT	Apr 11, 1988	Substantially Equivalent	Americal Corp.
K873461	LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)	Nov 06, 1987	Substantially Equivalent	Mallinckrodt Critical Care
K871632	NASOGASTRIC VOICETUBE	Sep 16, 1987	Substantially Equivalent	American Omni Medical, Inc.
K872366	AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE	Aug 17, 1987	Substantially Equivalent	Bivona Medical Technologies
K872616	BELL/MCKAY TRACHEAL TUBE	Aug 10, 1987	Substantially Equivalent	Sheridan Catheter Corp.
K871263	MULTIPLE PHARMA-PLAST TRACHEAL TUBE	Jun 15, 1987	Substantially Equivalent	Pharma-Plast USA, Inc.
K870470	TRACH MATE TRACHEAL TUBE	May 08, 1987	Substantially Equivalent	Mccormick Laboratories, Inc.
K870387	EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE	May 08, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K871204	CUFFED TRACHEAL TUBE (MULTIPLE)	Apr 21, 1987	Substantially Equivalent	Mallinckrodt Critical Care
K864533	HOOD BIFURCATED T-TUBE	Mar 09, 1987	Substantially Equivalent	Hood Laboratories
K864161	TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER	Nov 10, 1986	Substantially Equivalent	Toob-Cheq, Inc.
K862950	WHITE-SIPOSS TUBE, CAT NO WS-1	Oct 30, 1986	Substantially Equivalent	American Omni Medical, Inc.
K862238	BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE	Oct 15, 1986	Substantially Equivalent	Bivona Medical Technologies
K862666	UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)	Aug 01, 1986	Substantially Equivalent	Mallinckrodt Critical Care
K862347	ENDOTRACHEAL TUBE, ACCESSORY	Jul 11, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K860901	LASER RESISTANT TRACHEAL TUBE (TENTATIVE)	Jun 05, 1986	Substantially Equivalent	Mallinckrodt Critical Care
K861463	SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE	May 06, 1986	Substantially Equivalent	Shiley, Inc.
K861462	SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE	May 06, 1986	Substantially Equivalent	Shiley, Inc.
K861461	SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE	May 06, 1986	Substantially Equivalent	Shiley, Inc.
K861454	END TIDAL CO2 TUBE	May 06, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K860105	SPIRAL-FLEX	Mar 04, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K854632	ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE	Jan 03, 1986	Substantially Equivalent	Respiratory Support Products, Inc.
K853502	VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY	Oct 01, 1985	Substantially Equivalent	Bivona Medical Technologies
K852025	BRANDT TRACHEAL TUBE(TENTATIVE)	Aug 13, 1985	Substantially Equivalent	Mallinckrodt Critical Care
K852493	UNCUFFED HI-LO JET TRACHEAL TUBE	Jul 08, 1985	Substantially Equivalent	Mallinckrodt Critical Care
K844696	TROGIDE	Mar 04, 1985	Substantially Equivalent	Carmel Medical Devices
K843988	S.E.T. TUBE	Feb 21, 1985	Substantially Equivalent	Bfw Laboratories, Inc.
K844564	ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE	Feb 12, 1985	Substantially Equivalent	Sherwood Medical Co.
K844746	TRACHEAL TUBE W/AIRWAY INTUBATOR	Jan 14, 1985	Substantially Equivalent	Sheridan Catheter Corp.
K843936	MONTGOMERY SAFE-T-TUBE	Dec 14, 1984	Substantially Equivalent	Boston Medical Products, Inc.
K844296	TRACHEAL TUBE, REINFORCED, CUFFED	Dec 04, 1984	Substantially Equivalent	Sheridan Catheter Corp.
K843714	DOUBLE CONTOURED CUFF TRACHEAL TUBE	Oct 19, 1984	Substantially Equivalent	Ohmeda Medical
K841872	UNCUFFED REINFORCED TRACHEAL TUBE	Jul 26, 1984	Substantially Equivalent	Mallinckrodt Critical Care
K842635	SHERIDAN/ENDO-PAK	Jul 25, 1984	Substantially Equivalent	Sheridan Catheter Corp.
K842558	SHERIDAN/INTENSA TUBE	Jul 11, 1984	Substantially Equivalent	Sheridan Catheter Corp.
K842464	TRACHEAL TUBE/STETHOSCOPE	Jul 06, 1984	Substantially Equivalent	Mallinckrodt Critical Care
K840943	ENDO-JECT	May 25, 1984	Substantially Equivalent	Autovage
K840973	COLE TUBE-LATEX	Mar 30, 1984	Substantially Equivalent	Inmed Corp.
K833831	3-DAY BIOINDICATOR RELEASE FOR STERIL	Mar 21, 1984	Substantially Equivalent	Shiley, Inc.
K833807	ARGYLE JET TRACHEAL TUBE	Jan 13, 1984	Substantially Equivalent	Sherwood Medical Co.
K833197	TRACH SWIVE/CONNECTOR	Oct 28, 1983	Substantially Equivalent	Airlife, Inc.
K832629	INTUBATION KIT	Sep 20, 1983	Substantially Equivalent	Calbio, Inc.
K830631	TRACHEAL TUBE W/ILLUMINATING LOCATER	May 09, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K823757	SURGITEK ENDOTRACHEAL TUBE, LASER RESIS	Apr 28, 1983	Substantially Equivalent	Medical Engineering Corp.
K830504	SURGITEK ULTRA-LO CUFF	Apr 12, 1983	Substantially Equivalent	Mec/Surgitek Products
K830352	REINFORCED SILICONE TRACHEAL TUBE	Mar 08, 1983	Substantially Equivalent	Portex, Inc.
K822082	SHERIDAN/HVT,CF, UNCUFFED	Aug 10, 1982	Substantially Equivalent	Sheridan Catheter Corp.
K821670	ARGYLE TARTAN I TRACHEAL TUBE	Jun 24, 1982	Substantially Equivalent	Sherwood Medical Co.
K821456	ENDOTRACHEAL TUBE	Jun 17, 1982	Substantially Equivalent	Life-Line Products, Inc.
K821243	ENDOTRACHEAL TUBE	May 21, 1982	Substantially Equivalent	Life-Line Products, Inc.
K821180	TRACELON	May 21, 1982	Substantially Equivalent	Terumo Medical Corp.
K821027	SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL	May 03, 1982	Substantially Equivalent	Shiley, Inc.
K813373	VYGON ENDOTRACHEAL TUBES	Dec 22, 1981	Substantially Equivalent	Exco, Inc.
K812880	OHIO NON-REUSABLE TRACHEAL TUBE MAJILL	Nov 24, 1981	Substantially Equivalent	Airco/Ohio Medical Products
K812879	OHIO NON-REUSABLE TRACHEAL TUBE MURPHY	Nov 24, 1981	Substantially Equivalent	Airco/Ohio Medical Products
K812943	SLICK ENDOTRACHEAL TUBE	Nov 06, 1981	Substantially Equivalent	Polamedco, Inc.
K811937	ARGYLE TARTAN TRACHEAL TUBE	Jul 31, 1981	Substantially Equivalent	Sherwood Medical Co.
K811888	LINDHOLM ANATOMICAL TRACHEAL TUBE	Jul 23, 1981	Substantially Equivalent	Mallinckrodt Critical Care
K810763	OHIO DISPOSABLE TRACHEAL TUBE	Mar 27, 1981	Substantially Equivalent	Airco/Ohio Medical Products
K802505	DOUBLE LUMEN TRACHEAL TUBE	Mar 13, 1981	Substantially Equivalent	National Catheter Co. Div. Mallinckrodt
K810151	SLICK SET W/SURELOC EXTERNAL CONNECTOR	Feb 12, 1981	Substantially Equivalent	Polamedco, Inc.
K801213	CONCEPT ENDOTRACHEAL TUBE	May 28, 1980	Substantially Equivalent	Concept, Inc.
K801005	MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)	May 23, 1980	Substantially Equivalent	National Catheter Co. Div. Mallinckrodt
K800634	OHIO DISPOSABLE TRACHEAL TUBE	Apr 02, 1980	Substantially Equivalent	Ohio Medical Products
K792035	FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE	Oct 26, 1979	Substantially Equivalent	Bivona Medical Technologies
K791046	ENDOTRACHEAL TUBES, LONG & SHORT TERM	Jun 13, 1979	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K791045	MODEL GV-10 LANZ PRESSURE-VALVE	Jun 13, 1979	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K790927	OXYGENERATOR NO. M-049	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790575	TUBE, ARMORED TRACHEAL	Apr 13, 1979	Substantially Equivalent	National Patent Development Corp.
K790312	ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR	Feb 21, 1979	Substantially Equivalent	Respiratory Support Products, Inc.
K781713	ADAPTER, C/D SUCTION	Dec 12, 1978	Substantially Equivalent	Novametrix Medical Systems, Inc.
K781808	SLICK SET, CUFFED	Nov 29, 1978	Substantially Equivalent	Polamedco, Inc.
K781339	ENDOTRACHEAL TUBE	Aug 15, 1978	Substantially Equivalent	Life-Line Products, Inc.
K780900	SLICK SET	Jul 17, 1978	Substantially Equivalent	Polamedco, Inc.
K780583	FOME-CUF PVC	May 12, 1978	Substantially Equivalent	Bivona Medical Technologies
K771197	NORTON ENDOTRACHEAL	Aug 16, 1977	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760998	ENDOTRACHAEL TUBE AND HOLDER	Nov 19, 1976	Substantially Equivalent	Mcgaw Respiratory Therapy