Product code JOH
- Device name
- Tube Tracheostomy And Tube Cuff
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5800
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 ... | Covidien, LLC | 2025-12-29 |
| 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 |
| K203362 | TRACOE vario | Tracoe Medical GmbH | 2021-08-05 |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | 2020-06-01 |
| 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 Intr... | Cook Incorporated | 2019-12-12 |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | Covidien | 2019-03-22 |
| 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 Percutaneo... | Smiths Medical Asd, Inc. | 2018-05-08 |
| K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | 2018-05-07 |
| K172720 | TRACOE silcosoft Tracheostomy Tube | Tracoe Medical GmbH | 2018-04-27 |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | 2017-12-07 |
| K151404 | ProTrach Dualcare | Atos Medical AB | 2016-02-12 |
| 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 |
| 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 |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | Covidien | 2015-02-13 |
| K133528 | H&H EMERGENCY CRICOTHYROTOMY KIT | H & H Medical Corporation | 2014-07-03 |
| K133173 | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2014-05-23 |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Cook, Inc. | 2014-04-18 |
| K122932 | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | Fogless International AB | 2013-12-23 |
| K122235 | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | 2013-09-06 |
| K123699 | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013-08-12 |
| K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | Covidien | 2012-10-09 |
| K100995 | SHIKANI SPEAKING VALVE | Shikani Medical, LLC | 2010-06-25 |
| K093469 | CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS | Cook, Inc. | 2010-01-08 |
| K083641 | BIVONA TRACHEOSTOMY TUBES | Smiths Medical Asd, Inc. | 2009-02-23 |
| K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | Smiths Medical Asd, Inc. | 2008-09-12 |
| K072582 | PROVOX MICRON HME | Atos Medical AB | 2008-05-30 |
| K072148 | CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER | Cook, Inc. | 2007-10-03 |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | Mallinckrodt Medical | 2005-06-16 |
| 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 |
| K041485 | MARPAC MESSENGER MODEL #501 | Marpac, Inc. | 2004-08-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10887709194233 | Bivona | ICU MEDICAL, INC. | 2026-05-27 |
| 10887709194240 | Bivona | ICU MEDICAL, INC. | 2026-05-27 |
| 10887709194356 | Bivona | ICU MEDICAL, INC. | 2026-05-27 |
| 10887709194226 | Bivona | ICU MEDICAL, INC. | 2026-05-27 |
| 10884521103467 | Shiley | Covidien LP | 2019-05-12 |
| 10884521103450 | Shiley | Covidien LP | 2019-05-12 |
| 10859760005018 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10859760005025 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10859760005032 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10859760005063 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10859760005087 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10859760005148 | Passy-Muir | PASSY-MUIR, INC. | 2016-09-16 |
| 10884521097292 | Shiley | Covidien LP | 2016-04-04 |
| 10884521097285 | Shiley | Covidien LP | 2016-04-04 |
| 10884521097308 | Shiley | Covidien LP | 2016-04-04 |
| 10884521101630 | Shiley | Covidien LP | 2016-04-04 |
| 10884521081383 | Shiley | Covidien LP | 2015-10-22 |
| 10884521103436 | Shiley | Covidien LP | 2015-09-15 |
| 10884521097315 | Shiley | Covidien LP | 2015-09-15 |
| 10884521103443 | Shiley | Covidien LP | 2015-09-15 |
| 10351688067784 | Portex | ICU MEDICAL, INC. | 2015-09-01 |
| 10884521081468 | Shiley | Covidien LP | 2015-08-31 |
| 10884521081444 | Shiley | Covidien LP | 2015-08-28 |
| 10884521081451 | Shiley | Covidien LP | 2015-08-28 |
| 10884521081420 | Shiley | Covidien LP | 2015-08-28 |
| 10351688517340 | Bivona | ICU MEDICAL, INC. | 2015-07-29 |
| 10351688517425 | Bivona | ICU MEDICAL, INC. | 2015-07-29 |
| 10351688517401 | Bivona | ICU MEDICAL, INC. | 2015-07-29 |
| 10351688517333 | Bivona | ICU MEDICAL, INC. | 2015-07-29 |
| 10351688517388 | Bivona | ICU MEDICAL, INC. | 2015-07-29 |