ClearanceBrief
Panels › Anesthesiology › Product code JOH · Class 2

Tube Tracheostomy And Tube Cuff

Regulation 868.5800

1510(k)s in 12 months (109 all time)
5recalls in 12 months (131 all time)
114recalls that name a 510(k)
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Top companies in JOH

Company510(k)sRecalls
Nellcor Puritan Bennett Inc. (dba Covidien LP)057
Smiths Medical Asd, Inc.526
Cook Incorporated623
Bivona Medical Technologies150
Premier Dental Products Co014
Covidien74
Mallinckrodt Medical70
Rusch Intl.50
Passy-Muir, Inc.40
Smiths Industries Medical Systems, Inc.40
Decided510(k)Device and applicantCode
Dec 29, 2025K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult
Covidien, LLC
JOH
Nov 26, 2021K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheo
Smiths Medical Asd, Inc.
JOH
Aug 5, 2021K203362TRACOE vario
Tracoe Medical GmbH, DE
JOH
Jun 1, 2020K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
Covidien
JOH
Dec 12, 2019K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer T
Cook Incorporated
JOH
Mar 22, 2019K182861Shiley Neonatal/Pediatric Tracheostomy Tube
Covidien
JOH
May 8, 2018K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with
Smiths Medical Asd, Inc.
JOH
May 7, 2018K180034Weinmann Tracheostomy Exchange Set
Cook Incorporated
JOH
Apr 27, 2018K172720TRACOE silcosoft Tracheostomy Tube
Tracoe Medical GmbH, DE
JOH
Dec 7, 2017K170720Portex Blue Line Ultra Paediatric Tracheosomy Tube
Smiths Medical Asd, Inc.
JOH
Feb 12, 2016K151404ProTrach Dualcare
Atos Medical AB, SE
JOH
Jul 14, 2015K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with T
Covidien
JOH
Feb 24, 2015K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with
Covidien
JOH
Feb 13, 2015K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
Covidien
JOH
Jul 3, 2014K133528H&H EMERGENCY CRICOTHYROTOMY KIT
H & H Medical Corporation
JOH
May 23, 2014K133173RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
Teleflexmedical, Inc.
JOH
Apr 18, 2014K133597CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
Cook, Inc.
JOH
Dec 23, 2013K122932SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Fogless International AB, SE
JOH
Sep 6, 2013K122235RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
Teleflexmedical, Inc.
JOH
Aug 12, 2013K123699FAHL TRACHEOSTOMY TUBES (MULTIPLE)
Andreas Fahl Medizintechnik-Vertrieb GmbH, DE
JOH
Oct 9, 2012K122531SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
Covidien
JOH
Jun 25, 2010K100995SHIKANI SPEAKING VALVE
Shikani Medical, LLC
JOH
Jan 8, 2010K093469CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
Cook, Inc.
JOH
Feb 23, 2009K083641BIVONA TRACHEOSTOMY TUBES
Smiths Medical Asd, Inc.
JOH
Sep 12, 2008K081440BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
Smiths Medical Asd, Inc.
JOH
May 30, 2008K072582PROVOX MICRON HME
Atos Medical AB
JOH
Oct 3, 2007K072148CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
Cook, Inc.
JOH
Jun 16, 2005K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
Mallinckrodt Medical
JOH
Feb 18, 2005K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
Tracoe Medical GmbH
JOH
Aug 2, 2004K041485MARPAC MESSENGER MODEL #501
Marpac, Inc.
JOH
Jul 29, 2004K041044CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Cook, Inc.
JOH
Jul 13, 2004K041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
Smiths Medical, GB
JOH
Feb 13, 2004K040014PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
Portex , Ltd., GB
JOH
Nov 14, 2003K030787SHILEY FLEXTRA TRACHEOSTOMY TUBE
Nellcor Puritan Bennett, Inc.
JOH
Jul 18, 2003K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
Portex, Inc.
JOH
Mar 28, 2003K023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
Rusch Intl.
JOH
Mar 21, 2003K022212PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
Mentor Medical Limited, GB
JOH
Jul 30, 2002K013728TRACH VOX
Engineered Medical Systems
JOH
Feb 21, 2002K014102PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
Atos Medical AB, SE
JOH
Aug 15, 2001K011210THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
Rusch Intl.
JOH
Nov 8, 2000K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Mallinckrodt, Inc.
JOH
Apr 25, 2000K000964STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
Automatic Liquid Packaging, Inc.
JOH
Jun 11, 1999K990905PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
Passy-Muir, Inc.
JOH
Nov 13, 1998K970811DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
Pneumocare, Inc.
JOH
Oct 23, 1998K982128SHIKANI-FRENCH SPEAKING VALVE
Pilling Weck Surgical
JOH
Apr 14, 1998K972546RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
Rusch Intl.
JOH
Feb 24, 1998K980466PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Sims Portex, Inc.
JOH
Feb 23, 1998K973829IRRIGATION BOTTLE
Automatic Liquid Packaging, Inc.
JOH
Feb 13, 1998K972423RUSCH TRACHEOFIX-SET
Rusch Intl.
JOH
Jan 20, 1998K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
Smiths Industries Medical Systems, Inc.
JOH

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