đź“‹ FDA Reference
f p optiflow filtered nasal interface with anesthesia mask compatibility aa041j
Fisher &Paykel Healthcare
Summary: The f p optiflow filtered nasal interface is a medical device used for delivering filtered airflow to patients, compatible with anesthesia masks. It is primarily used by anesthesiologists and respiratory therapists.
FDA Clearance Information
Pathway
510K
Number
K234058 ↗
Decision Date
August 8, 2024
Product Code
BTT
Device Class
Class 2
Evidence
0 studies
The f p optiflow filtered nasal interface was cleared through the FDA 510(k) pathway on August 8, 2024. Manufactured by Fisher &Paykel Healthcare, it is classified as a Class 2 device under product code BTT.
What It Is
The f p optiflow filtered nasal interface is a device designed to deliver filtered airflow to patients, ensuring a clean and controlled respiratory environment. It is compatible with anesthesia masks, making it versatile for use in various clinical settings. The device helps maintain patient safety by reducing the risk of airborne contaminants during procedures.
Clinical Applications
This device is commonly used in operating rooms and intensive care units where anesthesia is administered. It is particularly beneficial for patients requiring respiratory support during surgical procedures. Anesthesiologists and respiratory therapists use it to ensure optimal airflow and filtration, especially in patients with compromised respiratory function.
Indications for Use
The device is indicated for use in patients requiring filtered airflow during medical procedures, particularly those involving anesthesia. It is suitable for patients with respiratory conditions or those undergoing surgeries where clean air delivery is critical.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is designed to be easily compatible with standard anesthesia masks, ensuring seamless integration into existing clinical workflows. Proper fitting and secure attachment are essential for optimal performance.
Frequently Asked Questions
What is the f p optiflow filtered nasal interface used for?
It is used to deliver filtered airflow to patients, particularly during anesthesia, to ensure clean and controlled respiratory support.
What specialties typically use this device?
Anesthesiologists and respiratory therapists commonly use this device in operating rooms and intensive care settings.
What are the FDA-cleared indications?
The device is indicated for providing filtered airflow to patients during medical procedures, especially those involving anesthesia.
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.