Identifiers
- 510(k) Number
- K052110 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 M-Series Pro CPAP System is a Ventilator, Non-Continuous (Respirator) designed to deliver continuous positive airway pressure (CPAP) therapy. It maintains a constant pressure level throughout the breathing cycle to treat obstructive sleep apnea, ensuring sustained airflow to prevent airway collapse during sleep. The device incorporates adaptive exhalation technology to reduce resistance during exhalation, enhancing patient comfort.
This system is intended for use in clinical and home settings, supplied as a reusable medical device. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance with a special advisory committee review in anesthesiology. The M-Series Pro CPAP System operates with interchangeable components, including a humidifier and SmartCard for data management, and requires proper storage to maintain functionality and hygiene. No specific sterility or MRI safety information is provided in the regulatory data.
Frequently asked questions
What is the M-Series Pro CPAP System used for?
The M-Series Pro CPAP System is designed to provide continuous positive airway pressure (CPAP) therapy. It maintains a constant pressure level throughout the breathing cycle to prevent airway collapse during sleep, effectively treating obstructive sleep apnea. This ensures sustained airflow, helping patients achieve uninterrupted rest.
How is the M-Series Pro CPAP System supplied, and is it reusable?
The M-Series Pro CPAP System is supplied as a reusable medical device. Unlike single-use devices, it is intended for repeated use in both clinical and home settings, provided it is properly maintained and cleaned according to manufacturer guidelines. This design supports long-term patient therapy while reducing waste.
Does the M-Series Pro CPAP System require any specific storage conditions?
While the regulatory data does not specify exact sterility requirements, proper storage is essential to maintain functionality and hygiene. The system should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures. Interchangeable components like the humidifier and SmartCard should also be stored according to manufacturer instructions to ensure optimal performance and data integrity.
What distinguishes the M-Series Pro CPAP System from other CPAP devices?
The M-Series Pro CPAP System incorporates adaptive exhalation technology, which reduces resistance during exhalation. This feature enhances patient comfort by making the breathing experience more natural compared to traditional CPAP devices. Additionally, its interchangeable components, such as the humidifier and SmartCard for data management, offer flexibility for personalized therapy settings.
Is the M-Series Pro CPAP System compatible with MRI procedures?
The regulatory data does not provide explicit information regarding MRI safety for the M-Series Pro CPAP System. If MRI compatibility is required, users should consult the manufacturer’s guidelines or contact Respironics directly for clarification, as some components or materials may pose risks in magnetic environments.
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: RESPIRONICS REMSTAR PRO M SERIES USER MANUAL Pdf Download, RESPIRONICS REMSTAR PRO M SERIES USER MANUAL Pdf Download, Respironics REMstar Pro M Series CPAP with C-Flex and SmartCard
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052110 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K052110 24 fields · synced Oct 1, 2026