Talking Trach
FDA 510(k) K062104 · Engineered Medical Systems, Inc.
510(k) numberK062104
Submission
- Device name
- Talking Trach
- Applicant
- Engineered Medical Systems, Inc.
Bonita Springs, FL, US - Received
- July 24, 2006
- Decision date
- April 20, 2007
- 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 |
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| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | 04/19/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | 03/14/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | 07/06/1999SE |
Questions and answers
When was Talking Trach cleared by the FDA?
Talking Trach (K062104) received a 510(k) decision of Substantially Equivalent on April 20, 2007, 270 days after the submission was received.
What is the product code of K062104?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.