đź“‹ FDA Reference
Ventilator Interface 9291 4
S & W Medico Teknik
Summary: The Ventilator Interface 9291 4 is a medical device used to connect patients to ventilators, primarily in critical care settings. It is utilized by healthcare professionals such as respiratory therapists and intensivists to ensure effective ventilation support.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K922314 ↗
Decision Date ?
December 17, 1992
Product Code ?
CBK
Device Class ?
Class 2
Evidence ?
0 studies
The Ventilator Interface 9291 4 by S & W Medico Teknik was cleared through the FDA 510(k) pathway on December 17, 1992. It is a Class 2 device under product code CBK.
What It Is
The Ventilator Interface 9291 4 is designed to facilitate the connection between a patient and a mechanical ventilator. It ensures that the ventilator can deliver the necessary respiratory support efficiently. The device is crucial in maintaining airway patency and ensuring adequate ventilation, especially in patients with compromised respiratory function.
FDA-Cleared Indications
- Connection of a patient to a mechanical ventilator for assisted ventilation.
- Use in patients who require mechanical ventilation because of respiratory insufficiency or failure.
Clinical Applications
- Providing a connection between the patient airway and a mechanical ventilator.
- Delivering ventilatory support in an intensive care setting.
- Delivering ventilatory support during emergency respiratory care.
- Supporting ventilation during procedures performed under general anesthesia when mechanical ventilation is required.
Practical Considerations
- The interface must be correctly fitted and securely connected to reduce air leaks and maintain effective ventilation.
- Compatibility with the specific ventilator, breathing circuit and airway equipment should be confirmed before use.
- Available sizes and configurations should be selected according to the patient’s anatomy and clinical needs.
- Application and monitoring should be performed by trained respiratory, anesthesia or critical-care personnel.
- MRI safety cannot be determined from the available FDA record; the device should not be taken into an MRI environment unless the manufacturer provides applicable MR safety labeling.
Frequently Asked Questions
What is the Ventilator Interface 9291 4 used for?
It is used to connect patients to mechanical ventilators, providing necessary respiratory support in critical care settings.
What specialties typically use this device?
Respiratory therapists, intensivists, anesthesiologists, and critical care physicians commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients needing mechanical ventilation due to respiratory failure or insufficiency.
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.