JOH — Tube Tracheostomy And Tube Cuff Class II
FDA Device Classification
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 | December 29, 2025 |
| K210833 | smiths medical asd | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach | November 26, 2021 |
| K203362 | tracoe medical | TRACOE vario | August 5, 2021 |
| K193077 | covidien | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | June 1, 2020 |
| K193133 | cook incorporated | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult | December 12, 2019 |
| K182861 | covidien | Shiley Neonatal/Pediatric Tracheostomy Tube | March 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 | April 27, 2018 |
| K170720 | smiths medical asd | Portex Blue Line Ultra Paediatric Tracheosomy Tube | December 7, 2017 |
| K151404 | atos medical | ProTrach Dualcare | February 12, 2016 |
| K150844 | covidien | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley | July 14, 2015 |
| K142296 | covidien | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shil | February 24, 2015 |
| K142298 | covidien | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard C | February 13, 2015 |
| K133528 | h and h medical corporation | H&H EMERGENCY CRICOTHYROTOMY KIT | July 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 | April 18, 2014 |
| K122932 | fogless international | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT | December 23, 2013 |
| K122235 | teleflexmedical | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET | September 6, 2013 |
| K123699 | andreas fahl medizintechnik-vertrieb | FAHL TRACHEOSTOMY TUBES (MULTIPLE) | August 12, 2013 |