Product Code: BTO FDA class 2 21 CFR 868.5800

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology

The Tube, Tracheostomy (W/Wo Connector) is a curved tube inserted through a surgical opening in the neck and into the trachea to establish and maintain a secure airway, used in patients requiring prolonged ventilatory support or airway protection. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTO, regulated under 21 CFR 868.5800 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

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510(k)s

128

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: BTO
Device Class: FDA class 2
Regulation Number: 868.5800
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 128 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242921	5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm	Jun 10, 2025	Substantially Equivalent	Vitaltec Corporation
K233713	Pilling Tracheostomy Tubes	Mar 22, 2024	Substantially Equivalent	Teleflex Medical
K192511	Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm	Jul 22, 2020	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
K173384	BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube	Apr 10, 2018	Substantially Equivalent	Smiths Medical Ads, Inc.
K120079	PRIMED TRACHEOSTOMY TUBES (MULTIPLE)	May 24, 2012	Substantially Equivalent	Primed Halberstadt Medizintechnik GmbH
K101721	WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA	Mar 24, 2011	Substantially Equivalent	Regulatory and Marketing Services, Inc.
K100950	VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE	Jul 13, 2010	Substantially Equivalent	Venner Medical (Singapore) Pte, Ltd.
K100480	ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH	Jun 11, 2010	Substantially Equivalent	Vitaltec Corporation
K100283	VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC	Apr 23, 2010	Substantially Equivalent	Cook, Inc.
K083031	PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT	Aug 18, 2009	Substantially Equivalent	Smiths Medical Asd, Inc.
K073702	PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR	Jun 26, 2008	Substantially Equivalent	Lazarus Medical, LLC
K062104	TALKING TRACH	Apr 20, 2007	Substantially Equivalent	Engineered Medical Systems, Inc.
K060945	PORTEX PERCUTANEOUS TRACHEOSTOMY KIT	Jun 19, 2006	Substantially Equivalent	Smiths Medical International
K051587	TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470	Oct 25, 2005	Substantially Equivalent	Tracoe Medical GmbH
K050379	CS MEDICAL ADULT TTCF CATHETER	Jul 12, 2005	Substantially Equivalent	Cs Medical, Inc.
K042684	WELL LEAD TRACHEOSTOMY TUBE	Feb 17, 2005	Substantially Equivalent	Well Lead Medical Instruments
K031553	SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES	Nov 18, 2003	Substantially Equivalent	Arcadia Medical Corporation
K030570	BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE	Sep 17, 2003	Substantially Equivalent	Portex , Ltd.
K030381	PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA	Aug 27, 2003	Substantially Equivalent	Portex , Ltd.
K021764	RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED	Jul 23, 2002	Substantially Equivalent	Rusch Intl.
K983000	CRICOTHYROTOMY TUBE	Oct 27, 1999	Substantially Equivalent	Polamedco, Inc.
K981080	SCOOP 1	Jun 17, 1998	Substantially Equivalent	Transtracheal Systems
K955461	TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).	Mar 19, 1997	Substantially Equivalent	VBM Medizintechnik GmbH
K960205	CPR TRACHEOTOMY CARE TRAY	Aug 27, 1996	Substantially Equivalent	Custom Pack Reliability
K962240	MOORE TRACHEOSTOMY TUBE	Aug 15, 1996	Substantially Equivalent	Boston Medical Products, Inc.
K953559	LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)	May 16, 1996	Substantially Equivalent	Seidel Medizin GmbH
K952416	TRACHEOSTOMY CARE KIT	Aug 09, 1995	Unknown	Medi-Flex Hospital Products, Inc.
K945407	SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT	Feb 27, 1995	Substantially Equivalent	Mallinckrodt Medical Tpi, Inc.
K945406	SSV PHONATE(TM) SHILEY SPEAKING VALVE	Feb 27, 1995	Substantially Equivalent	Mallinckrodt Medical Tpi, Inc.
K941470	TRACHEOSTOMY CARE KIT	Feb 14, 1995	Unknown	Clinical Resources, Inc.
K924193	TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)	Jun 16, 1993	Unknown	American Healthcare Corp.
K924191	TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL	Apr 02, 1993	Unknown	American Healthcare Corp.
K924195	TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES	Jan 06, 1993	Substantially Equivalent	American Healthcare Corp.
K924194	TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)	Jan 06, 1993	Unknown	American Healthcare Corp.
K923834	TRACHEOSTOMY CARE SET WITH GLOVES	Dec 10, 1992	Unknown	American Healthcare Corp.
K925249	CMI STOMA COVERS	Dec 03, 1992	Substantially Equivalent	Community Medical Center
K922749	LOW PROFILE TRACHEOSTOMY TUBE	Sep 02, 1992	Substantially Equivalent	Concord/Portex
K921281	TRACHEOSTOMY CARE KIT	Aug 27, 1992	Unknown	Trinity Laboratories, Inc.
K920281	TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE	Aug 27, 1992	Unknown	Trinity Laboratories, Inc.
K920604	BIVONA TRACHEAL T-TUBE STENT	Jul 27, 1992	Substantially Equivalent	Bivona Medical Technologies
K914743	EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF	Jul 10, 1992	Substantially Equivalent	Pertrach
K912124	TRACHEOSTOMY TUBE AND CUFF	Aug 16, 1991	Substantially Equivalent	Concord/Portex
K912469	BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE	Jun 19, 1991	Substantially Equivalent	Bivona Medical Technologies
K903730	D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES	Sep 25, 1990	Substantially Equivalent	Concord/Portex
K901920	PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE	Aug 17, 1990	Substantially Equivalent	Primecare, Inc.
K902281	MODIFIED SCOOP TRANSTRACHEAL CATHETERS	Aug 10, 1990	Substantially Equivalent	Transtracheal Systems
K901079	SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER	May 18, 1990	Substantially Equivalent	L H M Ent., Inc.
K901078	SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE	May 18, 1990	Substantially Equivalent	L H M Ent., Inc.
K900548	SHILEY PHONATION VALVE	Apr 23, 1990	Substantially Equivalent	Shiley, Inc.
K894096	STAT-TRACH(TM) VENTILATION CATHETER	Mar 16, 1990	Substantially Equivalent	Statron Corp.
K896798	TRACHEOSTOMY TRAY	Feb 22, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K895162	TRAUMAFUSE TRACH SHIELD	Jan 09, 1990	Substantially Equivalent	The Traumafuse Co.
K895130	HEIMLICH MICRO TRACH	Nov 07, 1989	Substantially Equivalent	Ballard Medical Products
K893866	HOOD PEDIATRIC TRACHEOSTOMY TUBE	Aug 07, 1989	Substantially Equivalent	Hood Laboratories
K885139	MODIFIED ADULT CRICOTHYROIDOTOMY KIT	May 25, 1989	Substantially Equivalent	Pertrach
K890342	AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)	Apr 27, 1989	Substantially Equivalent	Eastmed Enterprises, Inc.
K884730	SHILEY PERC TRACHEOSTOMY SYSTEM	Jan 17, 1989	Substantially Equivalent	Shiley, Inc.
K884015	PREMIER DECANNULATION STOPPER	Nov 03, 1988	Substantially Equivalent	Premier Dental
K884427	FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.	Nov 02, 1988	Substantially Equivalent	Bivona Medical Technologies
K882430	HOOD TRACHEAL STOMA BUTTON	Jun 28, 1988	Substantially Equivalent	Hood Laboratories
K880614	SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE	Mar 09, 1988	Substantially Equivalent	Shiley, Inc.
K880317	PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP	Feb 29, 1988	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K880316	PREFILLED WATER FOR IRRIGATION USP	Feb 29, 1988	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K874450	SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT	Feb 29, 1988	Substantially Equivalent	Surgitech C/O Collier, Shannon, Rill & Scott
K880247	MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES	Feb 12, 1988	Substantially Equivalent	Shiley, Inc.
K874742	QUICKTRACH	Dec 31, 1987	Substantially Equivalent	Posey Co.
K873499	TODD MEDICAL/SKILLED CARE PRODUCTS	Nov 24, 1987	Substantially Equivalent	Todd Medical, Inc.
K872486	LARKEL DEVICE W/ATTACHMENTS A-H	Sep 16, 1987	Substantially Equivalent	Seidel Medizin GmbH
K871199	MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.	Jun 08, 1987	Substantially Equivalent	Frederic J. Toye, M.D.
K870181	JOHNSON INTRATRACHEAL OXYGEN CATHETER SET	May 14, 1987	Substantially Equivalent	Cook, Inc.
K865061	SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE	Jan 15, 1987	Substantially Equivalent	Shiley, Inc.
K862436	TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)	Nov 03, 1986	Substantially Equivalent	Acutronic Medical Systems AG
K862909	RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM	Sep 09, 1986	Substantially Equivalent	Intl. Medical Devices , Ltd.
K862167	MINI-TRACH KIT	Aug 06, 1986	Substantially Equivalent	Portex, Inc.
K862267	FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES	Jun 18, 1986	Substantially Equivalent	Bivona Medical Technologies
K861645	MICRO-TRACHEOSTOMY CARE KIT	May 09, 1986	Substantially Equivalent	Aci Medical, Inc.
K853051	TRACHEAL TUBES	Apr 11, 1986	Substantially Equivalent	Erie Medical
K855130	TRACHEOSTOMY CARE KIT	Mar 04, 1986	Substantially Equivalent	Dynarex Corp.
K854252	TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER	Feb 03, 1986	Unknown	Transtracheal Systems
K860176	LARYNGECTOMY TUBE, CUFFED	Jan 27, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K853511	THE HOOD LIFE SAVER	Dec 19, 1985	Substantially Equivalent	Hood Laboratories
K853419	CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE	Dec 06, 1985	Unknown	Hood Laboratories
K852413	LGT TUBE	Sep 05, 1985	Substantially Equivalent	Mallinckrodt Critical Care
K852272	BIVONA TRACHEOSTOMA VALVE II	Jul 08, 1985	Substantially Equivalent	Bivona Medical Technologies
K851016	PASSY-MUIR TRACH VALVE	Jun 07, 1985	Substantially Equivalent	Passy & Passy, Inc.
K851462	BFW VOICE GENERATOR	May 28, 1985	Substantially Equivalent	Bfw Laboratories, Inc.
K850456	TRACHEOSTOMY CARE KIT	Mar 11, 1985	Substantially Equivalent	Excel Health Care Products
K850446	TRACHEOSTOMY CARE KIT	Mar 11, 1985	Substantially Equivalent	Paco Research Corp.
K850445	TRACHEOSTOMY CARE TRAY	Mar 11, 1985	Substantially Equivalent	Paco Research Corp.
K843785	WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR	Oct 23, 1984	Substantially Equivalent	Intl. Medical Devices , Ltd.
K843730	SHILEY DISPOS. DECANNULATION PLUG W/SW/	Oct 19, 1984	Substantially Equivalent	Shiley, Inc.
K843729	SHILEY DISPOS. CANNULA FENESTRATED LOW	Oct 19, 1984	Substantially Equivalent	Shiley, Inc.
K822440	PERCUTANEOUS CRICOTHYROIDOTOMY	Oct 15, 1984	Substantially Equivalent	Frederic J. Toye, M.D.
K832466	TRACHEAL TUBE 16 GAUGE-1.65MM-	Sep 19, 1984	Substantially Equivalent	Erie Medical
K842415	ALL-HANDS TRACHEOSTOMY CARE SET 0101	Jul 06, 1984	Substantially Equivalent	All-Hands Medical Supply, Inc.
K841266	MONTGOMERY TRACHEAL T-TUBE	Jun 14, 1984	Substantially Equivalent	E. Benson Hood Laboratories, Inc.
K840925	PEDIA-TRAKE CRICOTHYROTOMY KIT	May 02, 1984	Substantially Equivalent	Intl. Medical Devices , Ltd.
K841546	COMMUNI-TRACH TUBE	Apr 30, 1984	Substantially Equivalent	Implant Technology, Inc.
K833832	3-DAY BIOINDICATOR RELEASE FOR RESPIR	Mar 15, 1984	Substantially Equivalent	Shiley, Inc.
K840539	DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY	Mar 09, 1984	Substantially Equivalent	Shiley, Inc.
K834179	H.R. JAKOBI SURG. INSTRUMENTS #9 48	Jan 27, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K832498	PERCUTANEOUS TRACHEOSTOMY DEVICE	Oct 14, 1983	Substantially Equivalent	Frederic J. Toye, M.D.
K831720	ARGYLE SILICONE TRACHESTOMY TUBE W/LOW	Jul 07, 1983	Substantially Equivalent	Sherwood Medical Co.
K831511	TRACHEOSTOMY TUBE	Jul 07, 1983	Substantially Equivalent	Implant Technology, Inc.
K830509	EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-	Mar 29, 1983	Substantially Equivalent	Frederic J. Toye, M.D.
K823291	COMMUNITRACH TUBE	Jan 08, 1983	Substantially Equivalent	Implant Technology, Inc.
K822811	CONTAINERS OF STERILE WATER OS SALINE	Oct 27, 1982	Substantially Equivalent	American Pharmaseal Div. Ahsc
K822295	SURGI TEK'S DISPOS. INNER CANNULA FOR	Aug 20, 1982	Substantially Equivalent	Medical Engineering Corp.
K820099	TRACH TAPE	Feb 23, 1982	Substantially Equivalent	Stan-Pak Ent.
K811447	SHILEY DISPOSABLE CANNULA TRACH. TUBE	Jun 26, 1981	Substantially Equivalent	Shiley, Inc.
K811033	SHILEY LOW PRESSURE THIN-CUFFED TRACH	May 13, 1981	Substantially Equivalent	Shiley, Inc.
K810978	MONTGOMERY SILICONE TRACHEAL T-TUBE	May 05, 1981	Substantially Equivalent	Boston Medical Products, Inc.
K810575	MARTIN TRACH-SECURE	Mar 17, 1981	Substantially Equivalent	Diatek, Inc.
K810436	TRACHEOSTOMA VENT	Mar 04, 1981	Substantially Equivalent	Bivona Medical Technologies
K810321	REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)	Mar 04, 1981	Substantially Equivalent	National Catheter Co. Div. Mallinckrodt
K810106	SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE	Feb 02, 1981	Substantially Equivalent	Shiley, Inc.
K802916	MONTG. TRACHEAL CANNULA	Dec 19, 1980	Substantially Equivalent	Boston Medical Products, Inc.
K801379	CUFFED TRACHEA TUBE FOR USE W/PERTRACH	Sep 09, 1980	Substantially Equivalent	Frederic J. Toye, M.D.
K801931	MARTIN TRACH-SECURE	Aug 27, 1980	Substantially Equivalent	Acucare Medical, Inc.
K792069	TRACHEOSTOMY CARE KIT	Oct 30, 1979	Substantially Equivalent	National Patent Development Corp.
K790930	TRACHE FITTING M-307	Jun 22, 1979	Substantially Equivalent	Mem Medical, Inc.
K791044	TRACHEOSTOMY TUBES, SHORT AND LONG TERM	Jun 13, 1979	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K790437	TRACH CARE KIT	Apr 03, 1979	Substantially Equivalent	Abco Dealers, Inc.
K781729	TRACHEOTOMY TUBES	Oct 24, 1978	Substantially Equivalent	Tracoe Medical GmbH
K772138	ENDOTRACHEAL TUBE	Dec 20, 1977	Substantially Equivalent	Medline Industries, Inc.
K770218	SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE	Feb 09, 1977	Substantially Equivalent	Shiley, Inc.
K761258	DOVER LOW PRESSURE TRACHEAL TUBE	Dec 23, 1976	Substantially Equivalent	Will Ross Co.
K761190	TRACHEOSTOMY CARE KIT	Dec 16, 1976	Substantially Equivalent	Superior Plastic Products Corp.