JOH — Tube Tracheostomy And Tube Cuff Class II
FDA product code JOH covers "Tube Tracheostomy And Tube Cuff", a Class II medical device regulated under 21 CFR 868.5800. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOH
- Device Class
- Class II
- Regulation Number
- 868.5800
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251313 | Covidien | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with | Dec 29, 2025 |
| K210833 | Smiths Medical Asd | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach | Nov 26, 2021 |
| K203362 | Tracoe Medical | TRACOE vario | Aug 5, 2021 |
| K193077 | Covidien | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Jun 1, 2020 |
| K193133 | Cook Incorporated | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult | Dec 12, 2019 |
| K182861 | Covidien | Shiley Neonatal/Pediatric Tracheostomy Tube | Mar 22, 2019 |
| K173912 | Smiths Medical Asd | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc | May 8, 2018 |
| K180034 | Cook Incorporated | Weinmann Tracheostomy Exchange Set | May 7, 2018 |
| K172720 | Tracoe Medical | TRACOE silcosoft Tracheostomy Tube | Apr 27, 2018 |
| K170720 | Smiths Medical Asd | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Dec 7, 2017 |
| K151404 | Atos Medical | ProTrach Dualcare | Feb 12, 2016 |
| K150844 | Covidien | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley | Jul 14, 2015 |
| K142296 | Covidien | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shil | Feb 24, 2015 |
| K142298 | Covidien | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard C | Feb 13, 2015 |
| K133528 | H And H Medical Corporation | H&H EMERGENCY CRICOTHYROTOMY KIT | Jul 3, 2014 |
| K133173 | Teleflexmedical | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET | May 23, 2014 |
| K133597 | Cook | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUT | Apr 18, 2014 |
| K122932 | Fogless International | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | Dec 23, 2013 |
| K122235 | Teleflexmedical | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | Sep 6, 2013 |
| K123699 | Andreas Fahl Medizintechnik-Vertrieb | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | Aug 12, 2013 |