Trach Swive/Connector
FDA 510(k) K833197 · Airlife, Inc.
510(k) numberK833197
Submission
- Device name
- Trach Swive/Connector
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | Covidien, LLC | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | Covidien, LLC | 09/25/2025SE |
| K243579 | AeroJet Ventilation CatheterBTR · Traditional | Pipeline Medical Products, LLC | 08/13/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | William Cook Europe Aps | 06/11/2025SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | Flexicare Medical Limited. | 05/20/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K834077 | Single Use Nebulizer-Adjust-Air EntrainCAF · Traditional | 12/12/1983SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
| K821128 | Disposable Thermoplastic Rubber MouthBYP · Traditional | 05/13/1982SE |
Questions and answers
When was Trach Swive/Connector cleared by the FDA?
Trach Swive/Connector (K833197) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 39 days after the submission was received.
What is the product code of K833197?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.