Product Code: JOH FDA class 2 21 CFR 868.5800

Tube Tracheostomy And Tube Cuff

Anesthesiology

The Tube Tracheostomy and Tube Cuff is an airway management device used to maintain a patent airway through a surgically created opening in the trachea (tracheostomy), with an inflatable cuff to seal the airway and prevent aspiration in patients requiring long-term ventilatory support or airway protection. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOH and is regulated under 21 CFR 868.5800, within the Anesthesiology medical specialty. This device is classified as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

View on FDA

510(k)s

109

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JOH in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JOH
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 109 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251313	Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT	Dec 29, 2025	Substantially Equivalent	Covidien, LLC
K210833	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula	Nov 26, 2021	Substantially Equivalent	Smiths Medical Asd, Inc.
K203362	TRACOE vario	Aug 05, 2021	Substantially Equivalent	Tracoe Medical GmbH
K193077	Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff	Jun 01, 2020	Substantially Equivalent	Covidien
K193133	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, Weinmann-Multi Percutaneous Tracheostomy Exchange Set	Dec 12, 2019	Substantially Equivalent	Cook Incorporated
K182861	Shiley Neonatal/Pediatric Tracheostomy Tube	Mar 22, 2019	Substantially Equivalent	Covidien
K173912	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 Tracheostomy Kit with BLUselect Suctionaid tube	May 08, 2018	Substantially Equivalent	Smiths Medical Asd, Inc.
K180034	Weinmann Tracheostomy Exchange Set	May 07, 2018	Substantially Equivalent	Cook Incorporated
K172720	TRACOE silcosoft Tracheostomy Tube	Apr 27, 2018	Substantially Equivalent	Tracoe Medical GmbH
K170720	Portex Blue Line Ultra Paediatric Tracheosomy Tube	Dec 07, 2017	Substantially Equivalent	Smiths Medical Asd, Inc.
K151404	ProTrach Dualcare	Feb 12, 2016	Substantially Equivalent	Atos Medical AB
K150844	Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula	Jul 14, 2015	Substantially Equivalent	Covidien
K142296	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	Feb 24, 2015	Substantially Equivalent	Covidien
K142298	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	Feb 13, 2015	Substantially Equivalent	Covidien
K133528	H&H EMERGENCY CRICOTHYROTOMY KIT	Jul 03, 2014	Substantially Equivalent	H & H Medical Corporation
K133173	RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET	May 23, 2014	Substantially Equivalent	Teleflexmedical, Inc.
K133597	CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY	Apr 18, 2014	Substantially Equivalent	Cook, Inc.
K122932	SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT	Dec 23, 2013	Substantially Equivalent	Fogless International AB
K122235	RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET	Sep 06, 2013	Substantially Equivalent	Teleflexmedical, Inc.
K123699	FAHL TRACHEOSTOMY TUBES (MULTIPLE)	Aug 12, 2013	Substantially Equivalent	Andreas Fahl Medizintechnik-Vertrieb GmbH
K122531	SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T	Oct 09, 2012	Substantially Equivalent	Covidien
K100995	SHIKANI SPEAKING VALVE	Jun 25, 2010	Substantially Equivalent	Shikani Medical, LLC
K093469	CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS	Jan 08, 2010	Substantially Equivalent	Cook, Inc.
K083641	BIVONA TRACHEOSTOMY TUBES	Feb 23, 2009	Substantially Equivalent	Smiths Medical Asd, Inc.
K081440	BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES	Sep 12, 2008	Substantially Equivalent	Smiths Medical Asd, Inc.
K072582	PROVOX MICRON HME	May 30, 2008	Substantially Equivalent	Atos Medical AB
K072148	CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER	Oct 03, 2007	Substantially Equivalent	Cook, Inc.
K051416	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA	Jun 16, 2005	Substantially Equivalent	Mallinckrodt Medical
K043160	TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO	Feb 18, 2005	Substantially Equivalent	Tracoe Medical GmbH
K041485	MARPAC MESSENGER MODEL #501	Aug 02, 2004	Substantially Equivalent	Marpac, Inc.
K041044	CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET	Jul 29, 2004	Substantially Equivalent	Cook, Inc.
K041348	PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA	Jul 13, 2004	Substantially Equivalent	Smiths Medical
K040014	PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY	Feb 13, 2004	Substantially Equivalent	Portex , Ltd.
K030787	SHILEY FLEXTRA TRACHEOSTOMY TUBE	Nov 14, 2003	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K031057	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT	Jul 18, 2003	Substantially Equivalent	Portex, Inc.
K023918	RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS	Mar 28, 2003	Substantially Equivalent	Rusch Intl.
K022212	PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS	Mar 21, 2003	Substantially Equivalent	Mentor Medical Limited
K013728	TRACH VOX	Jul 30, 2002	Substantially Equivalent	Engineered Medical Systems
K014102	PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251	Feb 21, 2002	Substantially Equivalent	Atos Medical AB
K011210	THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY	Aug 15, 2001	Substantially Equivalent	Rusch Intl.
K003315	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA	Nov 08, 2000	Substantially Equivalent	Mallinckrodt, Inc.
K000964	STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109	Apr 25, 2000	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K990905	PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT	Jun 11, 1999	Substantially Equivalent	Passy-Muir, Inc.
K970811	DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN	Nov 13, 1998	Substantially Equivalent	Pneumocare, Inc.
K982128	SHIKANI-FRENCH SPEAKING VALVE	Oct 23, 1998	Substantially Equivalent	Pilling Weck Surgical
K972546	RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET	Apr 14, 1998	Substantially Equivalent	Rusch Intl.
K980466	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA	Feb 24, 1998	Substantially Equivalent	Sims Portex, Inc.
K973829	IRRIGATION BOTTLE	Feb 23, 1998	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K972423	RUSCH TRACHEOFIX-SET	Feb 13, 1998	Substantially Equivalent	Rusch Intl.
K972385	FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED	Jan 20, 1998	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K964056	RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE	Oct 10, 1997	Substantially Equivalent	Rusch Intl.
K971267	SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF	Sep 25, 1997	Substantially Equivalent	Mallinckrodt Medical
K963732	PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA	Jun 26, 1997	Substantially Equivalent	Mallinckrodt Medical
K970365	PASSY-MUIR O2 ADAPTER; PMA2000	Feb 12, 1997	Substantially Equivalent	Passy-Muir, Inc.
K962175	PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE	Jan 17, 1997	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K962714	PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000	Oct 28, 1996	Substantially Equivalent	Passy-Muir, Inc.
K962078	TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER	Oct 11, 1996	Unknown	Continental Medical Laboratories, Inc.
K962173	SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES	Oct 04, 1996	Substantially Equivalent	Mallinckrodt Medical
K961449	TRACHEOSTOMY TUBES TRACOE-FLEX	Sep 13, 1996	Substantially Equivalent	Tracoe Medical GmbH
K955564	RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE	Jun 28, 1996	Substantially Equivalent	Rusch, Inc.
K960429	PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA	May 02, 1996	Unknown	Smiths Industries Medical Systems, Inc.
K955680	SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED	Mar 13, 1996	Substantially Equivalent	Mallinckrodt Medical
K954749	MALLINCKRODT SHILEY 15MM CAP	Jan 24, 1996	Substantially Equivalent	Mallinckrodt Medical
K954661	THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,	Jan 19, 1996	Substantially Equivalent	Zipper Medical, Inc.
K955516	MONTGOMERY TRACHEOSTOMY SPEAKING VALVE	Dec 22, 1995	Substantially Equivalent	Boston Medical Products, Inc.
K952700	SUPERSLICK	Oct 31, 1995	Substantially Equivalent	Bivona Medical Technologies
K944451	PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)	Jul 07, 1995	Substantially Equivalent	Passy-Muir, Inc.
K945513	MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE	Jan 13, 1995	Substantially Equivalent	Mallinckrodt Medical
K945874	EUROMEDICAL POLY TRACHEOTOMY TUBE	Dec 27, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944178	BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES	Oct 27, 1994	Substantially Equivalent	Bivona Medical Technologies
K936224	REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS	Aug 30, 1994	Substantially Equivalent	Mallinckrodt Medical Tpi, Inc.
K921733	TRACHEOSTOMY CARE TRAY	Jun 15, 1994	Unknown	Medikmark, Inc.
K936133	PERCUTANEOUS TRACHEOSTOMY KIT	Mar 23, 1994	Unknown	Smiths Industries Medical Systems, Inc.
K932016	TRACHEOSTOMY CARE TRAY	Nov 03, 1993	Substantially Equivalent	Clinipad Corp.
K933412	SALINE SOLUTION-STERILE	Oct 01, 1993	Substantially Equivalent	Trinity Laboratories, Inc.
K931611	PERCUTANEOUS TRACHEOSTOMY TUBE KIT	Aug 27, 1993	Unknown	Crandall Medical Devices
K925288	TRACHEOSTOMY KIT	Aug 27, 1993	Unknown	Ajs Medical Co., Inc.
K923156	TRACHEOSTOMY CARE TRAY	Aug 18, 1993	Substantially Equivalent for Some Indications	Orion Life Systems, Inc.
K925020	TRACHEOSTOMY CARE KIT (STERILE)	Jul 07, 1993	Unknown	Customed, Inc.
K930895	SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF	Jul 02, 1993	Substantially Equivalent	Mallinckrodt Medical Tpi, Inc.
K924243	TRACHEOSTOMY CARE KIT	Jun 16, 1993	Unknown	Transidyne General Corp.
K925438	COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT	Feb 17, 1993	Substantially Equivalent	Aga Medical Products, Inc.
K922665	BIVONA HYPERFLEX TRACHEOSTOMY TUBE	Jan 07, 1993	Substantially Equivalent	Bivona Medical Technologies
K923878	BIVONA CUSTOMIZED TRACHEOSTOMY TUBES	Dec 29, 1992	Substantially Equivalent	Bivona Medical Technologies
K924660	TRACHEOSTOMY TUBE AND TUBE CUFF	Dec 11, 1992	Substantially Equivalent	Applied Medical Resources
K914471	NEEDLECRIC	Jun 29, 1992	Substantially Equivalent	Ajs Medical Co., Inc.
K913859	BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION	Jan 30, 1992	Substantially Equivalent	Bivona Medical Technologies
K914183	BIVONA CUFF MAINTENANCE DEVICE (CMD)	Oct 23, 1991	Substantially Equivalent	Bivona Medical Technologies
K914088	BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE	Oct 23, 1991	Substantially Equivalent	Bivona Medical Technologies
K913270	BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE	Aug 09, 1991	Substantially Equivalent	Bivona Medical Technologies
K912967	BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.	Jul 17, 1991	Substantially Equivalent	Bivona Medical Technologies
K911080	HYGIENA-TRACH	May 20, 1991	Substantially Equivalent	Apdyne Medical Co.
K910362	TRACHEOSTOMY CARE KIT	Apr 08, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K903435	SHILEY SPECIALIZED TRACHEOSTOMY TUBE	Oct 02, 1990	Substantially Equivalent	Shiley, Inc.
K903699	PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM	Sep 04, 1990	Substantially Equivalent	Passy & Passy, Inc.
K897102	HYDRASORB(TM)	Apr 23, 1990	Substantially Equivalent	Avitar, Inc.
K897005	BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE	Mar 16, 1990	Substantially Equivalent	Helix Medical, Inc.
K897059	HOOD SPEAKING VALVE	Mar 12, 1990	Substantially Equivalent	Hood Laboratories
K896548	MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE	Jan 22, 1990	Substantially Equivalent	Bivona Medical Technologies
K896547	MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE	Jan 22, 1990	Substantially Equivalent	Bivona Medical Technologies
K894614	BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE	Oct 13, 1989	Substantially Equivalent	Bivona Medical Technologies
K894613	BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE	Oct 13, 1989	Substantially Equivalent	Bivona Medical Technologies
K894050	MODIFIED DECANNULATION STOPPER	Aug 01, 1989	Substantially Equivalent	Premier Medical
K890194	SHILEY SPECIALIZED TRACHEOSTOMY TUBE	Jul 20, 1989	Substantially Equivalent	Shiley, Inc.
K885130	MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE	Feb 27, 1989	Substantially Equivalent	Bivona Medical Technologies
K885129	MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE	Feb 27, 1989	Substantially Equivalent	Bivona Medical Technologies
K812163	AIRE-CUF TRACHEOSTOMY TUBE	Sep 21, 1981	Substantially Equivalent	Bioana Surgical Instruments, Inc.
K812302	SHILEY FENESTRATED LOW PRESS. CUFFED	Sep 08, 1981	Substantially Equivalent	Shiley, Inc.
K760453	REGULATOR, PRESSURE, CUFF	Sep 13, 1976	Substantially Equivalent	Boehringer Laboratories