Portex Uniperc Percutaneous Dilation Tracheostomy Kit
FDA 510(k) K083031 · Smiths Medical Asd, Inc.
510(k) numberK083031
Submission
- Device name
- Portex Uniperc Percutaneous Dilation Tracheostomy Kit
- Applicant
- Smiths Medical Asd, Inc.
Hythe, Kent, GB - Received
- October 10, 2008
- Decision date
- August 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTO – Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…BTO · Special | Vitaltec Corporation | 09/11/2026SE |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…BTO · Traditional | Vitaltec Corporation | 06/10/2025SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | Teleflex Medical | 03/22/2024SE |
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube)…BTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/22/2020SE |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…BTO · Traditional | Smiths Medical Ads, Inc. | 04/10/2018SE |
| K120079 | Primed Tracheostomy Tubes (Multiple)BTO · Traditional | Primed Halberstadt Medizintechnik GmbH | 05/24/2012SE |
| K101721 | Well Lead Tracheostomy Tube and Disposable Inner CannulaBTO · Special | Regulatory and Marketing Services, Inc. | 03/24/2011SE |
| K100950 | Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/13/2010SE |
| K100480 | Rota-Trach Tracheostomy Tube Model Rota-TrachBTO · Traditional | Vitaltec Corporation | 06/11/2010SE |
| K100283 | Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…BTO · Traditional | Cook, Inc. | 04/23/2010SE |
More from Cook, Inc.
| 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 Uniperc Percutaneous Dilation Tracheostomy Kit cleared by the FDA?
Portex Uniperc Percutaneous Dilation Tracheostomy Kit (K083031) received a 510(k) decision of Substantially Equivalent on August 18, 2009, 312 days after the submission was received.
What is the product code of K083031?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.