JOH · Tube Tracheostomy And Tube Cuff
Anesthesiology · 21 CFR 868.5800 · Class 2
Overview
| Product Code | JOH |
|---|---|
| Device Name | Tube Tracheostomy And Tube Cuff |
| Regulation | 21 CFR 868.5800 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
| Life-Sustaining | Yes |
Identification
A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 109)
Showing 20 most recent of 109 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Dec 29, 2025 | SESE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | Smiths Medical Asd, Inc. | Nov 26, 2021 | SESE |
| K203362 | TRACOE vario | Tracoe Medical GmbH | Aug 5, 2021 | SESE |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | Jun 1, 2020 | SESE |
| 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 | Dec 12, 2019 | SESE |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | Covidien | Mar 22, 2019 | SESE |
| 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. | May 8, 2018 | SESE |
| K180034 | Weinmann Tracheostomy Exchange Set | Cook Incorporated | May 7, 2018 | SESE |
| K172720 | TRACOE silcosoft Tracheostomy Tube | Tracoe Medical GmbH | Apr 27, 2018 | SESE |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | Dec 7, 2017 | SESE |
| K151404 | ProTrach Dualcare | Atos Medical AB | Feb 12, 2016 | SESE |
| K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | Covidien | Jul 14, 2015 | SESE |
| K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | Covidien | Feb 24, 2015 | SESE |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | Covidien | Feb 13, 2015 | SESE |
| K133528 | H&H EMERGENCY CRICOTHYROTOMY KIT | H & H Medical Corporation | Jul 3, 2014 | SESE |
| K133173 | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | May 23, 2014 | SESE |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Cook, Inc. | Apr 18, 2014 | SESE |
| K122932 | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | Fogless International AB | Dec 23, 2013 | SESE |
| K122235 | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | Teleflexmedical, Inc. | Sep 6, 2013 | SESE |
| K123699 | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | Andreas Fahl Medizintechnik-Vertrieb GmbH | Aug 12, 2013 | SESE |
Top Applicants
- Bivona Medical Technologies — 15 clearances
- Mallinckrodt Medical — 7 clearances
- Covidien — 6 clearances
- Rusch Intl. — 5 clearances
- Smiths Medical Asd, Inc. — 5 clearances
