Blue Line Ultra Suctionaid Tracheostomy Tube
FDA 510(k) K030570 · Portex , Ltd.
510(k) numberK030570
Submission
- Device name
- Blue Line Ultra Suctionaid Tracheostomy Tube
- Applicant
- Portex , Ltd.
Hyth, Kent, GB - Received
- February 24, 2003
- Decision date
- September 17, 2003
- 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 |
|---|---|---|
| K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterCAZ · Traditional | 03/10/2004SE |
| K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…JOH · Traditional | 02/13/2004SE |
| K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)BTR · Traditional | 01/26/2004SE |
| K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterMQF · Traditional | 12/19/2003SE |
| K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)CAH · Traditional | 11/28/2003SE |
| K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaBTO · Traditional | 08/27/2003SE |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy KitJOH · Traditional | 07/18/2003SE |
| K031622 | Wallace Dual Lumen Oocyte Retrieval SetsMQE · Traditional | 06/26/2003SE |
| K023793 | 1ST Response Intermediate Manual ResuscitatorBTM · Traditional | 02/11/2003SE |
| K014115 | 1ST Response Manual Resuscitator, Model 85XXBTM · Traditional | 02/27/2002SE |
Questions and answers
When was Blue Line Ultra Suctionaid Tracheostomy Tube cleared by the FDA?
Blue Line Ultra Suctionaid Tracheostomy Tube (K030570) received a 510(k) decision of Substantially Equivalent on September 17, 2003, 205 days after the submission was received.
What is the product code of K030570?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.