Pilling Tracheostomy Tubes
FDA 510(k) K233713 · Teleflex Medical
510(k) numberK233713
Submission
- Device name
- Pilling Tracheostomy Tubes
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- November 20, 2023
- Decision date
- March 22, 2024
- 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 |
| 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 |
| K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy KitBTO · Traditional | Smiths Medical Asd, Inc. | 08/18/2009SE |
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| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | 07/03/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | 04/29/2025SE |
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| K241784 | Arrow® Nitinol WireDQX · Traditional | 09/18/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | 01/12/2024SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | 08/30/2023SE |
| K231924 | EZ-IO Intraosseous Vascular Access SystemFMI · Special | 07/25/2023SE |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special | 04/28/2023SE |
Questions and answers
When was Pilling Tracheostomy Tubes cleared by the FDA?
Pilling Tracheostomy Tubes (K233713) received a 510(k) decision of Substantially Equivalent on March 22, 2024, 123 days after the submission was received.
What is the product code of K233713?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.