FDA 510(k) Applications for Medical Device Product Code "BTO"
(Tube, Tracheostomy (W/Wo Connector))

FDA 510(k) Number Applicant Device Name Decision Date
K790437 ABCO DEALERS, INC. TRACH CARE KIT 04/03/1979
K861645 ACI MEDICAL, INC. MICRO-TRACHEOSTOMY CARE KIT 05/09/1986
K801931 ACUCARE MEDICAL, INC. MARTIN TRACH-SECURE 08/27/1980
K862436 ACUTRONIC MEDICAL SYSTEMS AG TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) 11/03/1986
K842415 ALL-HANDS MEDICAL SUPPLY, INC. ALL-HANDS TRACHEOSTOMY CARE SET 0101 07/06/1984
K924193 AMERICAN HEALTHCARE CORP. TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) 06/16/1993
K924194 AMERICAN HEALTHCARE CORP. TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) 01/06/1993
K924195 AMERICAN HEALTHCARE CORP. TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES 01/06/1993
K923834 AMERICAN HEALTHCARE CORP. TRACHEOSTOMY CARE SET WITH GLOVES 12/10/1992
K924191 AMERICAN HEALTHCARE CORP. TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL 04/02/1993
K822811 AMERICAN PHARMASEAL DIV. AHSC CONTAINERS OF STERILE WATER OS SALINE 10/27/1982
K031553 ARCADIA MEDICAL CORPORATION SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES 11/18/2003
K880317 AUTOMATIC LIQUID PACKAGING, INC. PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP 02/29/1988
K880316 AUTOMATIC LIQUID PACKAGING, INC. PREFILLED WATER FOR IRRIGATION USP 02/29/1988
K895130 BALLARD MEDICAL PRODUCTS HEIMLICH MICRO TRACH 11/07/1989
K851462 BFW LABORATORIES, INC. BFW VOICE GENERATOR 05/28/1985
K920604 BIVONA MEDICAL TECHNOLOGIES BIVONA TRACHEAL T-TUBE STENT 07/27/1992
K852272 BIVONA MEDICAL TECHNOLOGIES BIVONA TRACHEOSTOMA VALVE II 07/08/1985
K912469 BIVONA MEDICAL TECHNOLOGIES BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE 06/19/1991
K862267 BIVONA MEDICAL TECHNOLOGIES FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES 06/18/1986
K884427 BIVONA MEDICAL TECHNOLOGIES FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. 11/02/1988
K810436 BIVONA MEDICAL TECHNOLOGIES TRACHEOSTOMA VENT 03/04/1981
K802916 BOSTON MEDICAL PRODUCTS, INC. MONTG. TRACHEAL CANNULA 12/19/1980
K810978 BOSTON MEDICAL PRODUCTS, INC. MONTGOMERY SILICONE TRACHEAL T-TUBE 05/05/1981
K962240 BOSTON MEDICAL PRODUCTS, INC. MOORE TRACHEOSTOMY TUBE 08/15/1996
K941470 CLINICAL RESOURCES, INC. TRACHEOSTOMY CARE KIT 02/14/1995
K925249 COMMUNITY MEDICAL CENTER CMI STOMA COVERS 12/03/1992
K903730 CONCORD/PORTEX D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES 09/25/1990
K922749 CONCORD/PORTEX LOW PROFILE TRACHEOSTOMY TUBE 09/02/1992
K912124 CONCORD/PORTEX TRACHEOSTOMY TUBE AND CUFF 08/16/1991
K870181 COOK, INC. JOHNSON INTRATRACHEAL OXYGEN CATHETER SET 05/14/1987
K100283 COOK, INC. VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC 04/23/2010
K050379 CS MEDICAL INC. CS MEDICAL ADULT TTCF CATHETER 07/12/2005
K960205 CUSTOM PACK RELIABILITY CPR TRACHEOTOMY CARE TRAY 08/27/1996
K810575 DIATEK, INC. MARTIN TRACH-SECURE 03/17/1981
K855130 DYNAREX CORP. TRACHEOSTOMY CARE KIT 03/04/1986
K841266 E. BENSON HOOD LABORATORIES, INC. MONTGOMERY TRACHEAL T-TUBE 06/14/1984
K890342 EASTMED ENTERPRISES INC. AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) 04/27/1989
K062104 ENGINEERED MEDICAL SYSTEMS, INC. TALKING TRACH 04/20/2007
K832466 ERIE MEDICAL TRACHEAL TUBE 16 GAUGE-1.65MM- 09/19/1984
K853051 ERIE MEDICAL TRACHEAL TUBES 04/11/1986
K850456 EXCEL HEALTH CARE PRODUCTS TRACHEOSTOMY CARE KIT 03/11/1985
K791044 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. TRACHEOSTOMY TUBES, SHORT AND LONG TERM 06/13/1979
K801379 FREDERIC J. TOYE, M.D. CUFFED TRACHEA TUBE FOR USE W/PERTRACH 09/09/1980
K830509 FREDERIC J. TOYE, M.D. EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- 03/29/1983
K871199 FREDERIC J. TOYE, M.D. MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. 06/08/1987
K822440 FREDERIC J. TOYE, M.D. PERCUTANEOUS CRICOTHYROIDOTOMY 10/15/1984
K832498 FREDERIC J. TOYE, M.D. PERCUTANEOUS TRACHEOSTOMY DEVICE 10/14/1983
K853419 HOOD LABORATORIES CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE 12/06/1985
K893866 HOOD LABORATORIES HOOD PEDIATRIC TRACHEOSTOMY TUBE 08/07/1989
K882430 HOOD LABORATORIES HOOD TRACHEAL STOMA BUTTON 06/28/1988
K853511 HOOD LABORATORIES THE HOOD LIFE SAVER 12/19/1985
K834179 IMM ENTERPRISES LTD. H.R. JAKOBI SURG. INSTRUMENTS #9 48 01/27/1984
K841546 IMPLANT TECHNOLOGY, INC. COMMUNI-TRACH TUBE 04/30/1984
K823291 IMPLANT TECHNOLOGY, INC. COMMUNITRACH TUBE 01/08/1983
K831511 IMPLANT TECHNOLOGY, INC. TRACHEOSTOMY TUBE 07/07/1983
K840925 INTL. MEDICAL DEVICES LTD. PEDIA-TRAKE CRICOTHYROTOMY KIT 05/02/1984
K862909 INTL. MEDICAL DEVICES LTD. RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM 09/09/1986
K843785 INTL. MEDICAL DEVICES LTD. WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR 10/23/1984
K901078 L H M ENT., INC. SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE 05/18/1990
K901079 L H M ENT., INC. SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER 05/18/1990
K073702 LAZARUS MEDICAL LLC PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR 06/26/2008
K852413 MALLINCKRODT CRITICAL CARE LGT TUBE 09/05/1985
K945406 MALLINCKRODT MEDICAL TPI, INC. SSV PHONATE(TM) SHILEY SPEAKING VALVE 02/27/1995
K945407 MALLINCKRODT MEDICAL TPI, INC. SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT 02/27/1995
K952416 MEDI-FLEX HOSPITAL PRODUCTS, INC. TRACHEOSTOMY CARE KIT 08/09/1995
K822295 MEDICAL ENGINEERING CORP. SURGI TEK'S DISPOS. INNER CANNULA FOR 08/20/1982
K772138 MEDLINE INDUSTRIES, INC. ENDOTRACHEAL TUBE 12/20/1977
K790930 MEM MEDICAL, INC. TRACHE FITTING M-307 06/22/1979
K810321 NATIONAL CATHETER CO. DIV. MALLINCKRODT REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) 03/04/1981
K792069 NATIONAL PATENT DEVELOPMENT CORP. TRACHEOSTOMY CARE KIT 10/30/1979
K850446 PACO RESEARCH CORP. TRACHEOSTOMY CARE KIT 03/11/1985
K850445 PACO RESEARCH CORP. TRACHEOSTOMY CARE TRAY 03/11/1985
K851016 PASSY & PASSY, INC. PASSY-MUIR TRACH VALVE 06/07/1985
K914743 PERTRACH EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF 07/10/1992
K885139 PERTRACH MODIFIED ADULT CRICOTHYROIDOTOMY KIT 05/25/1989
K983000 POLAMEDCO, INC. CRICOTHYROTOMY TUBE 10/27/1999
K030570 PORTEX LTD. BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE 09/17/2003
K030381 PORTEX LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA 08/27/2003
K862167 PORTEX, INC. MINI-TRACH KIT 08/06/1986
K874742 POSEY CO. "QUICKTRACH" 12/31/1987
K884015 PREMIER DENTAL PREMIER DECANNULATION STOPPER 11/03/1988
K901920 PRIMECARE, INC. PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE 08/17/1990
K120079 PRIMED HALBERSTADT MEDIZINTECHNIK GMBH PRIMED TRACHEOSTOMY TUBES (MULTIPLE) 05/24/2012
K101721 REGULATORY AND MARKETING SERVICES, INC. WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA 03/24/2011
K021764 RUSCH INTL. RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED 07/23/2002
K872486 SEIDEL MEDIZIN GMBH LARKEL DEVICE W/ATTACHMENTS A-H 09/16/1987
K953559 SEIDEL MEDIZIN GMBH LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) 05/16/1996
K860176 SHERIDAN CATHETER CORP. LARYNGECTOMY TUBE, CUFFED 01/27/1986
K831720 SHERWOOD MEDICAL CO. ARGYLE SILICONE TRACHESTOMY TUBE W/LOW 07/07/1983
K833832 SHILEY, INC. 3-DAY BIOINDICATOR RELEASE FOR RESPIR 03/15/1984
K840539 SHILEY, INC. DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY 03/09/1984
K880247 SHILEY, INC. MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES 02/12/1988
K880614 SHILEY, INC. SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE 03/09/1988
K865061 SHILEY, INC. SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE 01/15/1987
K843729 SHILEY, INC. SHILEY DISPOS. CANNULA FENESTRATED LOW 10/19/1984
K843730 SHILEY, INC. SHILEY DISPOS. DECANNULATION PLUG W/SW/ 10/19/1984
K811447 SHILEY, INC. SHILEY DISPOSABLE CANNULA TRACH. TUBE 06/26/1981
K811033 SHILEY, INC. SHILEY LOW PRESSURE THIN-CUFFED TRACH 05/13/1981
K770218 SHILEY, INC. SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE 02/09/1977
K884730 SHILEY, INC. SHILEY PERC TRACHEOSTOMY SYSTEM 01/17/1989
K900548 SHILEY, INC. SHILEY PHONATION VALVE 04/23/1990
K810106 SHILEY, INC. SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE 02/02/1981
K173384 Smiths Medical ADS, Inc. BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube 04/10/2018
K083031 SMITHS MEDICAL ASD, INC. PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT 08/18/2009
K060945 SMITHS MEDICAL INTERNATIONAL PORTEX PERCUTANEOUS TRACHEOSTOMY KIT 06/19/2006
K820099 STAN-PAK ENT. TRACH TAPE 02/23/1982
K894096 STATRON CORP. STAT-TRACH(TM) VENTILATION CATHETER 03/16/1990
K761190 SUPERIOR PLASTIC PRODUCTS CORP. TRACHEOSTOMY CARE KIT 12/16/1976
K874450 SURGITECH C/O COLLIER, SHANNON, RILL & SCOTT SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT 02/29/1988
K895162 THE TRAUMAFUSE CO. TRAUMAFUSE TRACH SHIELD 01/09/1990
K873499 TODD MEDICAL, INC. TODD MEDICAL/SKILLED CARE PRODUCTS 11/24/1987
K781729 TRACOE MEDICAL GMBH TRACHEOTOMY TUBES 10/24/1978
K051587 TRACOE MEDICAL GMBH TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 10/25/2005
K902281 TRANSTRACHEAL SYSTEMS MODIFIED SCOOP TRANSTRACHEAL CATHETERS 08/10/1990
K981080 TRANSTRACHEAL SYSTEMS SCOOP 1 06/17/1998
K854252 TRANSTRACHEAL SYSTEMS TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER 02/03/1986
K921281 TRINITY LABORATORIES, INC. TRACHEOSTOMY CARE KIT 08/27/1992
K920281 TRINITY LABORATORIES, INC. TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE 08/27/1992
K955461 VBM MEDIZINTECHNIK GMBH TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). 03/19/1997
K100950 VENNER MEDICAL (SINGAPORE) PTE LTD VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE 07/13/2010
K192511 Venner Medical (Singapore) PTE Ltd Venner PneuXÖ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 9.0 mm 07/22/2020
K100480 VITALTEC CORPORATION ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH 06/11/2010
K042684 WELL LEAD MEDICAL INSTRUMENTS WELL LEAD TRACHEOSTOMY TUBE 02/17/2005
K896798 WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) TRACHEOSTOMY TRAY 02/22/1990
K761258 WILL ROSS CO. DOVER LOW PRESSURE TRACHEAL TUBE 12/23/1976


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