Rusch Tracflex Plus Tracheostomy Tube Set
FDA 510(k) K122235 · Teleflexmedical, Inc.
510(k) numberK122235
Submission
- Device name
- Rusch Tracflex Plus Tracheostomy Tube Set
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- July 26, 2012
- Decision date
- September 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOH – Tube Tracheostomy And Tube Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code JOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | Covidien, LLC | 12/29/2025SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | Smiths Medical Asd, Inc. | 11/26/2021SE |
| K203362 | TRACOE varioJOH · Traditional | Tracoe Medical GmbH | 08/05/2021SE |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH · Traditional | Covidien | 06/01/2020SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | Cook Incorporated | 12/12/2019SE |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy TubeJOH · Traditional | Covidien | 03/22/2019SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | Smiths Medical Asd, Inc. | 05/08/2018SE |
| K180034 | Weinmann Tracheostomy Exchange SetJOH · Traditional | Cook Incorporated | 05/07/2018SE |
| K172720 | TRACOE silcosoft Tracheostomy TubeJOH · Traditional | Tracoe Medical GmbH | 04/27/2018SE |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy TubeJOH · Traditional | Smiths Medical Asd, Inc. | 12/07/2017SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | 08/01/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | 07/27/2023SE |
| K192324 | Sheridan Spiral-Flex Endotracheal TubesBTR · Traditional | 12/06/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | 07/01/2019SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | 05/24/2019SE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | 05/08/2019SESK |
| K181852 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 10/12/2018SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | 08/02/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | 02/12/2018SE |
| K161770 | Rusch Silicone Foley CatheterEZL · Traditional | 05/05/2017SE |
Questions and answers
When was Rusch Tracflex Plus Tracheostomy Tube Set cleared by the FDA?
Rusch Tracflex Plus Tracheostomy Tube Set (K122235) received a 510(k) decision of Substantially Equivalent on September 6, 2013, 407 days after the submission was received.
What is the product code of K122235?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.