Product code BTO

Device name: Tube, Tracheostomy (W/Wo Connector)
Medical specialty: Anesthesiology
Device class: 2
Regulation number: 868.5800
Review panel: AN
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
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 St...	Vitaltec Corporation	2025-06-10
K233713	Pilling Tracheostomy Tubes	Teleflex Medical	2024-03-22
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	Venner Medical (Singapore) Pte, Ltd.	2020-07-22
K173384	BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube	Smiths Medical Ads, Inc.	2018-04-10
K120079	PRIMED TRACHEOSTOMY TUBES (MULTIPLE)	Primed Halberstadt Medizintechnik GmbH	2012-05-24
K101721	WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA	Regulatory and Marketing Services, Inc.	2011-03-24
K100950	VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE	Venner Medical (Singapore) Pte, Ltd.	2010-07-13
K100480	ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH	Vitaltec Corporation	2010-06-11
K100283	VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC	Cook, Inc.	2010-04-23
K083031	PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT	Smiths Medical Asd, Inc.	2009-08-18
K073702	PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR	Lazarus Medical, LLC	2008-06-26
K062104	TALKING TRACH	Engineered Medical Systems, Inc.	2007-04-20
K060945	PORTEX PERCUTANEOUS TRACHEOSTOMY KIT	Smiths Medical International	2006-06-19
K051587	TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470	Tracoe Medical GmbH	2005-10-25
K050379	CS MEDICAL ADULT TTCF CATHETER	Cs Medical, Inc.	2005-07-12
K042684	WELL LEAD TRACHEOSTOMY TUBE	Well Lead Medical Instruments	2005-02-17
K031553	SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES	Arcadia Medical Corporation	2003-11-18
K030570	BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE	Portex , Ltd.	2003-09-17
K030381	PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA	Portex , Ltd.	2003-08-27
K021764	RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED	Rusch Intl.	2002-07-23
K983000	CRICOTHYROTOMY TUBE	Polamedco, Inc.	1999-10-27
K981080	SCOOP 1	Transtracheal Systems	1998-06-17
K955461	TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).	VBM Medizintechnik GmbH	1997-03-19
K960205	CPR TRACHEOTOMY CARE TRAY	Custom Pack Reliability	1996-08-27
K962240	MOORE TRACHEOSTOMY TUBE	Boston Medical Products, Inc.	1996-08-15
K953559	LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)	Seidel Medizin GmbH	1996-05-16
K952416	TRACHEOSTOMY CARE KIT	Medi-Flex Hospital Products, Inc.	1995-08-09
K945407	SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT	Mallinckrodt Medical Tpi, Inc.	1995-02-27
K945406	SSV PHONATE(TM) SHILEY SPEAKING VALVE	Mallinckrodt Medical Tpi, Inc.	1995-02-27
K941470	TRACHEOSTOMY CARE KIT	Clinical Resources, Inc.	1995-02-14

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00348783011135	Premier Decann Stopper	PREMIER DENTAL PRODUCTS COMPANY	2026-05-27
10192253052893	Argyle	Cardinal Health 200, LLC	2024-07-15
10192253052992	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052985	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052909	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052916	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052923	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052930	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052954	Argyle	Cardinal Health 200, LLC	2024-02-16
10192253052978	Argyle	Cardinal Health 200, LLC	2024-02-16
08885009190820	Venner™ PneuX P.Y.™ TT MRI	VENNER MEDICAL (SINGAPORE) PTE. LTD.	2016-09-24
08885009190844	Venner™ PneuX P.Y.™ TT MRI	VENNER MEDICAL (SINGAPORE) PTE. LTD.	2016-09-24
08885009190837	Venner™ PneuX P.Y.™ TT MRI	VENNER MEDICAL (SINGAPORE) PTE. LTD.	2016-09-24
M3681398181	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681398171	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681398141	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681398161	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681398151	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681395161	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
M3681395151	JOHN BUNN	GF HEALTH PRODUCTS, INC.	2016-08-31
10351688005892	Portex	ICU MEDICAL, INC.	2015-07-29
10351688018854	Portex	ICU MEDICAL, INC.	2015-07-29
10351688036711	Portex	ICU MEDICAL, INC.	2015-07-29
10351688041128	Portex	ICU MEDICAL, INC.	2015-07-29
10351688041135	Portex	ICU MEDICAL, INC.	2015-07-29
10351688041142	Portex	ICU MEDICAL, INC.	2015-07-29
10351688041159	Portex	ICU MEDICAL, INC.	2015-07-29
10351688517364	Bivona	ICU MEDICAL, INC.	2015-07-29
10351688517371	Bivona	ICU MEDICAL, INC.	2015-07-29
10351688517395	Bivona	ICU MEDICAL, INC.	2015-07-29

Product code BTO

Related 510(k) Records#

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