đź“‹ FDA Reference
Portex Blue Line Ultra Paediatric Tracheosomy Tube
Smiths Medical Asd
Summary: The Portex Blue Line Ultra Pediatric Tracheostomy Tube is a medical device used to maintain an open airway in pediatric patients requiring long-term ventilation. It is primarily used by pediatric specialists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170720 ↗
Decision Date ?
December 7, 2017
Product Code ?
JOH
Device Class ?
Class 2
Evidence ?
0 studies
The Portex Blue Line Ultra Pediatric Tracheostomy Tube, manufactured by Smiths Medical, was cleared via the FDA 510(k) pathway on December 7, 2017. It is classified as a Class 2 device under product code JOH.
What It Is
The Portex Blue Line Ultra Pediatric Tracheostomy Tube is designed for pediatric patients who need a secure airway for ventilation. It features a soft, flexible tube that is inserted into the trachea through a stoma in the neck. The device helps maintain airway patency and is often used in patients with chronic respiratory conditions or those requiring long-term mechanical ventilation.
FDA-Cleared Indications
- Pediatric patients requiring a tracheostomy for airway management.
- Pediatric patients requiring maintenance of a patent airway.
- Pediatric patients requiring connection to a ventilator or breathing circuit through a tracheostomy.
Clinical Applications
- Maintaining airway patency after pediatric tracheostomy placement.
- Providing an airway for children who require prolonged mechanical ventilation.
- Connecting a pediatric tracheostomy airway to compatible standard ventilator or respiratory equipment.
- Managing airway obstruction when a tracheostomy is clinically indicated.
Practical Considerations
- The tube must be selected in an appropriate pediatric size and configuration for the child's airway anatomy and clinical needs.
- Placement and tube changes require trained clinicians; airway position and ventilation should be confirmed according to institutional practice.
- The tube should be checked for compatibility with the intended ventilator, humidification system, suction equipment and other respiratory accessories.
- Follow the manufacturer’s instructions for handling, cleaning, replacement and use of any obturator, inner cannula or cuff-related components included with the specific model.
- MRI safety and conditional-use information should be verified for the exact tube model and all attached components before an MRI examination.
Frequently Asked Questions
What is the Portex Blue Line Ultra Pediatric Tracheostomy Tube used for?
It is used to maintain an open airway in pediatric patients who require long-term ventilation or have obstructive airway conditions.
What specialties typically use this device?
Pediatric intensive care specialists and pediatric otolaryngologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for pediatric patients needing a tracheostomy for airway management, particularly those with obstructive airway conditions or requiring prolonged mechanical ventilation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.