Portex Blue Line Ultra Paediatric Tracheosomy Tube
FDA 510(k) K170720 · Smiths Medical Asd, Inc.
510(k) numberK170720
Submission
- Device name
- Portex Blue Line Ultra Paediatric Tracheosomy Tube
- Applicant
- Smiths Medical Asd, Inc.
Plymouth, MN, US - Received
- March 9, 2017
- Decision date
- December 7, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K151404 | ProTrach DualcareJOH · Traditional | Atos Medical AB | 02/12/2016SE |
More from Atos Medical AB
| 510(k) | Device | Decision |
|---|---|---|
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | 05/31/2024SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | 11/26/2021SE |
| K211634 | Hypodermic Needle-Pro EDGE Safety DeviceFMI · Special | 08/26/2021SE |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration SetsFPA · Traditional | 09/18/2020SE |
| K181699 | Level 1 Convective WarmerDWJ · Traditional | 07/26/2018SE |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal…MIA · Traditional | 06/14/2018SE |
| K172823 | Portex NRFit Epidural NeedlesBSP · Traditional | 06/12/2018SE |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…BSP · Traditional | 06/01/2018SE |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connectorPWH · Traditional | 05/17/2018SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | 05/08/2018SE |
Questions and answers
When was Portex Blue Line Ultra Paediatric Tracheosomy Tube cleared by the FDA?
Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720) received a 510(k) decision of Substantially Equivalent on December 7, 2017, 273 days after the submission was received.
What is the product code of K170720?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.