FDA 510(k) Applications for Medical Device Product Code "JOH"
(Tube Tracheostomy And Tube Cuff)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123699 | ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | 08/12/2013 |
| K151404 | ATOS MEDICAL AB | ProTrach Dualcare | 02/12/2016 |
| K014102 | ATOS MEDICAL AB | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | 02/21/2002 |
| K072582 | ATOS MEDICAL AB | PROVOX MICRON HME | 05/30/2008 |
| K973829 | AUTOMATIC LIQUID PACKAGING, INC. | IRRIGATION BOTTLE | 02/23/1998 |
| K000964 | AUTOMATIC LIQUID PACKAGING, INC. | STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 | 04/25/2000 |
| K962078 | CONTINENTAL MEDICAL LABORATORIES, INC. | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER | 10/11/1996 |
| K193133 | Cook Incorporated | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinm | 12/12/2019 |
| K180034 | Cook Incorporated | Weinmann Tracheostomy Exchange Set | 05/07/2018 |
| K072148 | COOK, INC. | CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER | 10/03/2007 |
| K093469 | COOK, INC. | CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS | 01/08/2010 |
| K041044 | COOK, INC. | CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET | 07/29/2004 |
| K133597 | COOK, INC. | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | 04/18/2014 |
| K193077 | Covidien | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | 06/01/2020 |
| K142296 | Covidien | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | 02/24/2015 |
| K150844 | COVIDIEN | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | 07/14/2015 |
| K122531 | COVIDIEN | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | 10/09/2012 |
| K142298 | Covidien | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | 02/13/2015 |
| K182861 | Covidien | Shiley Neonatal/Pediatric Tracheostomy Tube | 03/22/2019 |
| K013728 | ENGINEERED MEDICAL SYSTEMS | TRACH VOX | 07/30/2002 |
| K122932 | FOGLESS INTERNATIONAL AB | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | 12/23/2013 |
| K133528 | H&H MEDICAL CORPORATION | H&H EMERGENCY CRICOTHYROTOMY KIT | 07/03/2014 |
| K954749 | MALLINCKRODT MEDICAL | MALLINCKRODT SHILEY 15MM CAP | 01/24/1996 |
| K963732 | MALLINCKRODT MEDICAL | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | 06/26/1997 |
| K962173 | MALLINCKRODT MEDICAL | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | 10/04/1996 |
| K955680 | MALLINCKRODT MEDICAL | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | 03/13/1996 |
| K971267 | MALLINCKRODT MEDICAL | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | 09/25/1997 |
| K051416 | MALLINCKRODT MEDICAL | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | 06/16/2005 |
| K003315 | MALLINCKRODT, INC. | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | 11/08/2000 |
| K041485 | MARPAC, INC. | MARPAC MESSENGER MODEL #501 | 08/02/2004 |
| K022212 | MENTOR MEDICAL LIMITED | PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS | 03/21/2003 |
| K030787 | NELLCOR PURITAN BENNETT, INC. | SHILEY FLEXTRA TRACHEOSTOMY TUBE | 11/14/2003 |
| K962714 | PASSY-MUIR, INC. | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | 10/28/1996 |
| K990905 | PASSY-MUIR, INC. | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT | 06/11/1999 |
| K970365 | PASSY-MUIR, INC. | PASSY-MUIR O2 ADAPTER; PMA2000 | 02/12/1997 |
| K982128 | PILLING WECK SURGICAL | SHIKANI-FRENCH SPEAKING VALVE | 10/23/1998 |
| K970811 | PNEUMOCARE, INC. | DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN | 11/13/1998 |
| K040014 | PORTEX LTD. | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY | 02/13/2004 |
| K031057 | PORTEX, INC. | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | 07/18/2003 |
| K023918 | RUSCH INTL. | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS | 03/28/2003 |
| K972546 | RUSCH INTL. | RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET | 04/14/1998 |
| K972423 | RUSCH INTL. | RUSCH TRACHEOFIX-SET | 02/13/1998 |
| K964056 | RUSCH INTL. | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE | 10/10/1997 |
| K011210 | RUSCH INTL. | THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY | 08/15/2001 |
| K955564 | RUSCH, INC. | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | 06/28/1996 |
| K100995 | SHIKANI MEDICAL, LLC | SHIKANI SPEAKING VALVE | 06/25/2010 |
| K980466 | SIMS PORTEX, INC. | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | 02/24/1998 |
| K972385 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | 01/20/1998 |
| K960429 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA | 05/02/1996 |
| K962175 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | 01/17/1997 |
| K041348 | SMITHS MEDICAL | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA | 07/13/2004 |
| K081440 | SMITHS MEDICAL ASD, INC. | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | 09/12/2008 |
| K083641 | SMITHS MEDICAL ASD, INC. | BIVONA TRACHEOSTOMY TUBES | 02/23/2009 |
| K173912 | Smiths Medical ASD, Inc. | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Trache | 05/08/2018 |
| K170720 | Smiths Medical ASD, Inc. | Portex Blue Line Ultra Paediatric Tracheosomy Tube | 12/07/2017 |
| K210833 | Smiths Medical ASD, Inc. | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | 11/26/2021 |
| K133173 | Teleflex Medical, Inc. | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | 05/23/2014 |
| K122235 | Teleflex Medical, Inc. | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | 09/06/2013 |
| K961449 | TRACOE MEDICAL GMBH | TRACHEOSTOMY TUBES TRACOE-FLEX | 09/13/1996 |
| K043160 | TRACOE MEDICAL GMBH | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | 02/18/2005 |
| K172720 | TRACOE medical GmbH | TRACOE silcosoft Tracheostomy Tube | 04/27/2018 |
| K203362 | TRACOE medical GmbH | TRACOE vario | 08/05/2021 |
| K954661 | ZIPPER MEDICAL, INC. | THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER, | 01/19/1996 |
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