Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0
510(k) K081086
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081086 | Date13 Aug 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube is a tracheal tube with a suction port positioned above the cuff. Designed for patients requiring prolonged mechanical ventilation, it facilitates the removal of secretions from above the cuff while maintaining tube placement, helping to reduce the risk of ventilator-associated pneumonia (VAP). This device is classified as a tracheal tube with or without a connector and is intended for airway management in critical care settings.
This single-use device is supplied sterile and is intended for use in operating rooms, intensive care units, and other clinical environments requiring endotracheal intubation. Available in sizes 6.0 through 9.0, it features a high-volume, low-pressure SoftSeal reverse cuff for improved patient comfort and reduced trauma. The device holds an FDA 510(k) clearance under the Anesthesiology Advisory Committee and is regulated under the classification of Class II medical devices.
Other devices from Smiths Medical Asd, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube designed for?
This device is specifically designed for patients requiring prolonged mechanical ventilation. The suction port positioned above the cuff helps remove secretions from that area while maintaining tube placement, which may help reduce the risk of ventilator-associated pneumonia (VAP). It is intended for airway management in critical care settings such as operating rooms and intensive care units.
How is the Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube supplied?
The device is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining device integrity for one-time clinical use.
What sizes are available for the Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube?
The device is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. These sizes cater to a range of patient needs in critical care, ensuring appropriate fit and functionality for different clinical scenarios.
Does the Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube have a reusable option?
No, this device is explicitly designed for single-use only. The sterile packaging and intended use align with clinical best practices to minimize infection risks and ensure patient safety.
How should the Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube be stored?
The device should be stored in its original, unopened sterile packaging until use. It should be kept in a clean, dry environment, protected from direct sunlight and extreme temperatures, to preserve sterility and functionality.