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
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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