DreamStation 2 System, DreamStation 2 Advanced System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200480 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 DreamStation 2 System and DreamStation 2 Advanced System are classified as Non-Continuous (Respirator) Ventilators, designed for use in spontaneously breathing patients. These devices deliver positive airway pressure therapy to treat obstructive sleep apnea (OSA) by maintaining open airways during sleep, ensuring continuous airflow and reducing apnea events.
These systems are intended for use in both home and institutional settings, such as hospitals. They are single-use or reusable depending on manufacturer guidelines, with regulatory clearance under FDA 510(k) classification. The DreamStation 2 Advanced System includes enhanced features for improved patient comfort and ease of use, adhering to FDA-authorized specifications for ventilatory support in anesthesia and respiratory care.
Frequently asked questions
What clinical conditions is the DreamStation 2 System primarily designed to treat, and how does it differ from a traditional CPAP machine?
The DreamStation 2 System is specifically designed to treat obstructive sleep apnea (OSA) by delivering positive airway pressure therapy to maintain open airways during sleep. Unlike traditional CPAP machines, which provide a single, fixed pressure, the DreamStation 2 System offers advanced features like adaptive pressure adjustments and enhanced comfort settings, making it suitable for both home and institutional use. This ensures continuous airflow and reduces apnea events, catering to patients who may require more tailored respiratory support.
Are the DreamStation 2 System and DreamStation 2 Advanced System reusable or single-use, and how should they be handled?
The DreamStation 2 System and DreamStation 2 Advanced System are designed to be reusable, following manufacturer guidelines for cleaning and maintenance. Proper handling includes adhering to Respironics’ instructions for disinfection and sterilization to ensure patient safety and device longevity. The manufacturer’s guidelines should always be consulted for specific cleaning protocols.
What regulatory pathway was followed for FDA clearance of the DreamStation 2 System, and what does this mean for clinicians?
The DreamStation 2 System received FDA clearance through a 510(k) traditional pathway, determined to be *substantially equivalent* to a legally marketed device under the Anesthesiology advisory committee. This means the device has undergone rigorous review to ensure safety and effectiveness for its intended use—delivering positive airway pressure therapy for obstructive sleep apnea in spontaneously breathing patients. Clinicians can rely on this clearance as evidence of regulatory validation for its clinical application.
How do I determine if the DreamStation 2 System is compatible with my facility’s existing infrastructure or patient needs?
The DreamStation 2 System is designed for use in both home and institutional settings, including hospitals, and supports non-continuous ventilatory therapy for spontaneously breathing patients. While compatibility depends on specific workflows, the system’s advanced features—such as adaptive pressure and ease of use—are intended to integrate seamlessly with standard respiratory care protocols. Consult Respironics’ technical specifications or a respiratory specialist to confirm compatibility with your facility’s existing equipment and patient population.
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: DreamStation 2 Auto CPAP Advanced - Philips, PHILIPS Respironics DreamStation 2 Advanced CPAP User Manual, PDF DreamStation 2 Auto CPAP Advanced - intushealthcare.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200480 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K200480 24 fields · synced Sep 20, 2026