FDA Product Code
FDA Product Code JOH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5800
510(k) Clearances — 109 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Covidien, LLC | 2025-12-29 | Traditional | PDF ↗ |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | Smiths Medical Asd, Inc. | 2021-11-26 | Traditional | PDF ↗ |
| K203362 | TRACOE vario | Tracoe Medical GmbH | 2021-08-05 | Traditional | PDF ↗ |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | 2020-06-01 | Traditional | PDF ↗ |
| 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 | Cook Incorporated | 2019-12-12 | Special | PDF ↗ |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | Covidien | 2019-03-22 | Traditional | PDF ↗ |
| 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 | Smiths Medical Asd, Inc. | 2018-05-08 | Traditional | PDF ↗ |
| K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018-05-07 | Traditional | PDF ↗ |
| K172720 | TRACOE silcosoft Tracheostomy Tube | Tracoe Medical GmbH | 2018-04-27 | Traditional | PDF ↗ |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | 2017-12-07 | Traditional | PDF ↗ |
| K151404 | ProTrach Dualcare | Atos Medical AB | 2016-02-12 | Traditional | PDF ↗ |
| K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | Covidien | 2015-07-14 | Traditional | PDF ↗ |
| K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | Covidien | 2015-02-24 | Traditional | PDF ↗ |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | Covidien | 2015-02-13 | Traditional | PDF ↗ |
| K133528 | H&H EMERGENCY CRICOTHYROTOMY KIT | H & H Medical Corporation | 2014-07-03 | Traditional | PDF ↗ |
| K133173 | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2014-05-23 | Traditional | PDF ↗ |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Cook, Inc. | 2014-04-18 | Traditional | PDF ↗ |
| K122932 | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | Fogless International AB | 2013-12-23 | Traditional | PDF ↗ |
| K122235 | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2013-09-06 | Special | PDF ↗ |
| K123699 | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013-08-12 | Traditional | PDF ↗ |
| K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | Covidien | 2012-10-09 | Special | PDF ↗ |
| K100995 | SHIKANI SPEAKING VALVE | Shikani Medical, LLC | 2010-06-25 | Traditional | PDF ↗ |
| K093469 | CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS | Cook, Inc. | 2010-01-08 | Special | PDF ↗ |
| K083641 | BIVONA TRACHEOSTOMY TUBES | Smiths Medical Asd, Inc. | 2009-02-23 | Traditional | PDF ↗ |
| K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | Smiths Medical Asd, Inc. | 2008-09-12 | Traditional | PDF ↗ |
| K072582 | PROVOX MICRON HME | Atos Medical AB | 2008-05-30 | Traditional | PDF ↗ |
| K072148 | CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER | Cook, Inc. | 2007-10-03 | Special | PDF ↗ |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | Mallinckrodt Medical | 2005-06-16 | Special | PDF ↗ |
| K043160 | TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO | Tracoe Medical GmbH | 2005-02-18 | Traditional | PDF ↗ |
| K041485 | MARPAC MESSENGER MODEL #501 | Marpac, Inc. | 2004-08-02 | Traditional | PDF ↗ |
| K041044 | CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET | Cook, Inc. | 2004-07-29 | Traditional | PDF ↗ |
| K041348 | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA | Smiths Medical | 2004-07-13 | Traditional | PDF ↗ |
| K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY | Portex , Ltd. | 2004-02-13 | Traditional | PDF ↗ |
| K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE | Nellcor Puritan Bennett, Inc. | 2003-11-14 | Traditional | PDF ↗ |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Portex, Inc. | 2003-07-18 | Traditional | PDF ↗ |
| K023918 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS | Rusch Intl. | 2003-03-28 | Traditional | PDF ↗ |
| K022212 | PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS | Mentor Medical Limited | 2003-03-21 | Traditional | PDF ↗ |
| K013728 | TRACH VOX | Engineered Medical Systems | 2002-07-30 | Traditional | PDF ↗ |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | Atos Medical AB | 2002-02-21 | Special | PDF ↗ |
| K011210 | THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY | Rusch Intl. | 2001-08-15 | Traditional | PDF ↗ |
| K003315 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Mallinckrodt, Inc. | 2000-11-08 | Special | PDF ↗ |
| K000964 | STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 | Automatic Liquid Packaging, Inc. | 2000-04-25 | Special | PDF ↗ |
| K990905 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT | Passy-Muir, Inc. | 1999-06-11 | Traditional | PDF ↗ |
| K970811 | DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN | Pneumocare, Inc. | 1998-11-13 | Traditional | PDF ↗ |
| K982128 | SHIKANI-FRENCH SPEAKING VALVE | Pilling Weck Surgical | 1998-10-23 | Traditional | PDF ↗ |
| K972546 | RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET | Rusch Intl. | 1998-04-14 | Traditional | PDF ↗ |
| K980466 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Sims Portex, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K973829 | IRRIGATION BOTTLE | Automatic Liquid Packaging, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K972423 | RUSCH TRACHEOFIX-SET | Rusch Intl. | 1998-02-13 | Traditional | PDF ↗ |
| K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | Smiths Industries Medical Systems, Inc. | 1998-01-20 | Traditional | PDF ↗ |
| K964056 | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE | Rusch Intl. | 1997-10-10 | Traditional | PDF ↗ |
| K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | Mallinckrodt Medical | 1997-09-25 | Traditional | PDF ↗ |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | Mallinckrodt Medical | 1997-06-26 | Traditional | PDF ↗ |
| K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 | Passy-Muir, Inc. | 1997-02-12 | Traditional | PDF ↗ |
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | Smiths Industries Medical Systems, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | Passy-Muir, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K962078 | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER | Continental Medical Laboratories, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | Mallinckrodt Medical | 1996-10-04 | Traditional | PDF ↗ |
| K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX | Tracoe Medical GmbH | 1996-09-13 | Traditional | PDF ↗ |
| K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE | Rusch, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA | Smiths Industries Medical Systems, Inc. | 1996-05-02 | Traditional | PDF ↗ |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | Mallinckrodt Medical | 1996-03-13 | Traditional | PDF ↗ |
| K954749 | MALLINCKRODT SHILEY 15MM CAP | Mallinckrodt Medical | 1996-01-24 | Traditional | PDF ↗ |
| K954661 | THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER, | Zipper Medical, Inc. | 1996-01-19 | Traditional | PDF ↗ |
| K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE | Boston Medical Products, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K952700 | SUPERSLICK | Bivona Medical Technologies | 1995-10-31 | Traditional | PDF ↗ |
| K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) | Passy-Muir, Inc. | 1995-07-07 | Traditional | PDF ↗ |
| K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE | Mallinckrodt Medical | 1995-01-13 | Traditional | PDF ↗ |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | Regulatory & Marketing Services, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Bivona Medical Technologies | 1994-10-27 | Traditional | PDF ↗ |
| K936224 | REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS | Mallinckrodt Medical Tpi, Inc. | 1994-08-30 | Traditional | PDF ↗ |
| K921733 | TRACHEOSTOMY CARE TRAY | Medikmark, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K936133 | PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Industries Medical Systems, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K932016 | TRACHEOSTOMY CARE TRAY | Clinipad Corp. | 1993-11-03 | Traditional | PDF ↗ |
| K933412 | SALINE SOLUTION-STERILE | Trinity Laboratories, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K925288 | TRACHEOSTOMY KIT | Ajs Medical Co., Inc. | 1993-08-27 | Traditional | PDF ↗ |
| K931611 | PERCUTANEOUS TRACHEOSTOMY TUBE KIT | Crandall Medical Devices | 1993-08-27 | Traditional | PDF ↗ |
| K923156 | TRACHEOSTOMY CARE TRAY | Orion Life Systems, Inc. | 1993-08-18 | Traditional | PDF ↗ |
| K925020 | TRACHEOSTOMY CARE KIT (STERILE) | Customed, Inc. | 1993-07-07 | Traditional | PDF ↗ |
| K930895 | SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF | Mallinckrodt Medical Tpi, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K924243 | TRACHEOSTOMY CARE KIT | Transidyne General Corp. | 1993-06-16 | Traditional | PDF ↗ |
| K925438 | COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT | Aga Medical Products, Inc. | 1993-02-17 | Traditional | PDF ↗ |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1993-01-07 | Traditional | PDF ↗ |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1992-12-29 | Traditional | PDF ↗ |
| K924660 | TRACHEOSTOMY TUBE AND TUBE CUFF | Applied Medical Resources | 1992-12-11 | Traditional | PDF ↗ |
| K914471 | NEEDLECRIC | Ajs Medical Co., Inc. | 1992-06-29 | Traditional | PDF ↗ |
| K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | Bivona Medical Technologies | 1992-01-30 | Traditional | PDF ↗ |
| K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-10-23 | Traditional | PDF ↗ |
| K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | Bivona Medical Technologies | 1991-10-23 | Traditional | PDF ↗ |
| K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-08-09 | Traditional | PDF ↗ |
| K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | Bivona Medical Technologies | 1991-07-17 | Traditional | PDF ↗ |
| K911080 | HYGIENA-TRACH | Apdyne Medical Co. | 1991-05-20 | Traditional | PDF ↗ |
| K910362 | TRACHEOSTOMY CARE KIT | Megadyne Medical Products, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | Shiley, Inc. | 1990-10-02 | Traditional | PDF ↗ |
| K903699 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM | Passy & Passy, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K897102 | HYDRASORB(TM) | Avitar, Inc. | 1990-04-23 | Traditional | PDF ↗ |
| K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE | Helix Medical, Inc. | 1990-03-16 | Traditional | PDF ↗ |
| K897059 | HOOD SPEAKING VALVE | Hood Laboratories | 1990-03-12 | Traditional | PDF ↗ |
| K896547 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1990-01-22 | Traditional | PDF ↗ |
| K896548 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1990-01-22 | Traditional | PDF ↗ |
Product code JOH · Class II · Anesthesiology. Data: openFDA.