AutoSet Spirit CPAP System
FDA 510(k)Class II (US FDA 510(k))
by Resmed Corp
Identifiers
- 510(k) Number
- K013843 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AutoSet Spirit CPAP System is a non-continuous ventilator designed for the treatment of obstructive sleep apnea. It delivers continuous positive airway pressure (CPAP) therapy to maintain an open airway during sleep, reducing apnea events and improving oxygenation by adjusting pressure automatically based on patient needs.
This device is intended for home use and is supplied as a reusable medical device. It operates with disposable tubing and masks, and its regulatory classification is Class II under FDA regulations (510(k) clearance). The system is not MRI-safe and requires proper storage in a clean, dry environment to maintain functionality and hygiene.
Frequently asked questions
What is the AutoSet Spirit CPAP System used for?
The AutoSet Spirit CPAP System is designed specifically for treating obstructive sleep apnea (OSA). It delivers continuous positive airway pressure (CPAP) therapy to keep the airway open during sleep, reducing apnea events and improving oxygen levels. The device automatically adjusts pressure based on the patient’s breathing patterns to provide personalized support throughout the night.
Is the AutoSet Spirit CPAP System reusable or single-use?
The AutoSet Spirit CPAP System itself is a reusable medical device, intended for long-term home use. However, it requires disposable components such as tubing and masks, which must be replaced as recommended to maintain hygiene and functionality. This design ensures both durability of the core device and adherence to clinical best practices for patient safety.
How should the AutoSet Spirit CPAP System be stored?
To preserve functionality and hygiene, the AutoSet Spirit CPAP System should be stored in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions can compromise the device’s performance or integrity. Regular cleaning of reusable parts, as per manufacturer guidelines, is also essential to prevent contamination and ensure reliable operation.
Can the AutoSet Spirit CPAP System be used in an MRI scanner?
No, the AutoSet Spirit CPAP System is not MRI-safe. If MRI imaging is required for a patient using this device, the device must be removed from the room and stored safely during the procedure. Always follow clinical protocols and consult with radiology staff to ensure proper handling and safety during MRI scans.
What regulatory approval does the AutoSet Spirit CPAP System hold?
The AutoSet Spirit CPAP System holds FDA 510(k) clearance, confirming it meets U.S. regulatory standards for non-continuous ventilators used in the treatment of obstructive sleep apnea. This classification ensures the device has undergone rigorous testing to demonstrate substantial equivalence to a legally marketed predicate device, aligning with FDA guidelines for Class II medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF AutoSet Spirit - ResMed, ResMed AutoSet Spirit User's Manual | Manualzz, ResMed AutoSet Spirit CPAP Systems User's Manual, Resmed S8 Autoset Spirit Respiratory Product User Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013843 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed Corp
Sources (1)
- FDA 510(k) K013843 24 fields · synced Oct 1, 2026