Well Lead Tracheostomy Tube and Disposable Inner Cannula
FDA 510(k) K101721 · Regulatory and Marketing Services, Inc.
510(k) numberK101721
Submission
- Device name
- Well Lead Tracheostomy Tube and Disposable Inner Cannula
- Applicant
- Regulatory and Marketing Services, Inc.
Appollo Beach, FL, US - Received
- June 18, 2010
- Decision date
- March 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
Questions and answers
When was Well Lead Tracheostomy Tube and Disposable Inner Cannula cleared by the FDA?
Well Lead Tracheostomy Tube and Disposable Inner Cannula (K101721) received a 510(k) decision of Substantially Equivalent on March 24, 2011, 279 days after the submission was received.
What is the product code of K101721?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.