📋 FDA Reference
Aura Cpap Patient Interface
Aeiomed
Summary: The Aura CPAP Patient Interface is a device used in the management of obstructive sleep apnea. It is typically used by sleep specialists and respiratory therapists to ensure effective CPAP therapy for patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K042130 ↗
Decision Date ?
September 8, 2004
Product Code ?
BZD
Device Class ?
Class 2
Evidence ?
0 studies
The Aura CPAP Patient Interface by Aeiomed was cleared through the FDA 510(k) pathway on September 8, 2004. It is a Class 2 medical device.
What It Is
The Aura CPAP Patient Interface is a component of continuous positive airway pressure (CPAP) therapy systems, designed to deliver pressurized air to patients with obstructive sleep apnea. It works by maintaining an open airway during sleep, preventing apnea episodes. The interface typically includes a mask that fits over the nose or mouth, connected to a CPAP machine.
FDA-Cleared Indications
- Use as a patient interface for CPAP therapy in the management of obstructive sleep apnea.
- Delivery of pressurized air from a compatible CPAP system through a properly fitted patient mask.
Clinical Applications
- CPAP therapy for patients diagnosed with obstructive sleep apnea.
- Use in sleep laboratories under the supervision of sleep medicine professionals.
- Use at home as part of a prescribed CPAP system.
- Interface fitting and adjustment by qualified clinicians or respiratory therapists to support effective CPAP delivery.
Practical Considerations
- The interface should be fitted to the patient's facial anatomy to reduce air leakage and improve comfort.
- Available sizing and mask configuration should be confirmed before use; the supplied product documentation should be followed.
- Compatibility with the patient's CPAP machine, tubing and connectors should be verified.
- The interface should not be used without appropriate clinical evaluation and a prescribed CPAP system.
- MRI compatibility should not be assumed. Check the device labeling and all attached components before an MRI examination.
Related Literature
The linked study, 'Interface of epilepsy and sleep disorders,' explores the relationship between sleep disorders and epilepsy. It highlights that sleep deprivation can provoke seizures and discusses the use of polysomnography in diagnosing sleep disorders in patients with suspected seizures. While not directly related to the Aura CPAP, it underscores the importance of addressing sleep disorders in neurological conditions.
Frequently Asked Questions
What is the Aura CPAP Patient Interface used for?
It is used to deliver continuous positive airway pressure to patients with obstructive sleep apnea, helping to keep their airways open during sleep.
What specialties typically use this device?
Sleep specialists and respiratory therapists commonly use this device in sleep medicine.
What are the FDA-cleared indications?
The device is indicated for the treatment of obstructive sleep apnea, helping to maintain open airways during sleep.
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.