đź“‹ FDA Reference
optiflow switch filtered nasal interface with co2 sampling aa042j
Fisher &Paykel Healthcare
Summary: The Optiflow Switch Filtered Nasal Interface with CO2 Sampling is a medical device used for delivering humidified oxygen therapy while allowing CO2 monitoring. It is typically used by respiratory therapists and clinicians in settings such as hospitals and clinics.
FDA Clearance Information
Pathway
510K
Number
K253479 ↗
Decision Date
December 19, 2025
Product Code
BTT
Device Class
Class 2
Evidence
0 studies
The Optiflow Switch Filtered Nasal Interface was cleared via the FDA 510(k) pathway on December 19, 2025. Manufactured by Fisher & Paykel Healthcare, it is classified as a Class II device under product code BTT.
What It Is
The Optiflow Switch Filtered Nasal Interface is a device designed to deliver humidified oxygen therapy to patients while simultaneously allowing for CO2 sampling. It features a filtered nasal interface that ensures effective delivery of oxygen and monitoring of exhaled carbon dioxide, which is crucial for assessing respiratory function. This device is particularly useful in managing patients with respiratory conditions requiring precise oxygen delivery and monitoring.
Clinical Applications
This device is commonly used in respiratory therapy, particularly in hospital settings such as intensive care units and emergency departments. It is beneficial for patients with conditions like COPD, asthma, or those recovering from surgery who require supplemental oxygen. Respiratory therapists and clinicians use it to ensure patients receive adequate oxygenation while monitoring their CO2 levels to adjust treatment as needed.
Indications for Use
The FDA indications suggest this device is intended for patients who require supplemental oxygen therapy with concurrent CO2 monitoring. It is suitable for individuals with respiratory conditions where precise oxygen delivery and respiratory monitoring are critical.
Practical Considerations
The Optiflow Switch is available in various sizes to accommodate different patient anatomies, ensuring a comfortable fit. It is compatible with standard oxygen delivery systems and requires proper technique for fitting and securing to maximize efficacy and patient comfort.
Frequently Asked Questions
What is the Optiflow Switch Filtered Nasal Interface used for?
It is used for delivering humidified oxygen therapy and monitoring CO2 levels in patients with respiratory conditions.
What specialties typically use this device?
Respiratory therapists and clinicians in intensive care, emergency medicine, and pulmonology commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients needing supplemental oxygen therapy with CO2 monitoring, particularly those with respiratory conditions.
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.