Resmed S8 Pioneer CPAP System
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K041209 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 Resmed S8 Pioneer CPAP System is a non-continuous ventilator designed for the treatment of obstructive sleep apnea (OSA) in adult patients. It operates as a self-adjusting positive airway pressure (PAP) device, delivering variable or fixed-pressure airflow to maintain open airways during sleep.
This system is intended for home use and is supplied as a reusable medical device. It includes regulatory authorisation under the FDA’s 510(k) clearance (K041209) as a Class 2 Anesthesiology device (product code BZD). The device is not MRI-safe and requires proper storage and maintenance as per manufacturer guidelines to ensure functionality and hygiene.
Frequently asked questions
What is the primary use of the Resmed S8 Pioneer CPAP System, and who is it designed for?
The Resmed S8 Pioneer CPAP System is a self-adjusting positive airway pressure (PAP) device designed specifically for the treatment of obstructive sleep apnea (OSA) in adult patients. It delivers variable or fixed-pressure airflow to help maintain open airways during sleep, making it suitable for home use.
Is the Resmed S8 Pioneer CPAP System intended for single-use or reusable applications?
The Resmed S8 Pioneer CPAP System is supplied as a reusable medical device. It is not designed for single-use, and proper maintenance and hygiene practices are required to ensure its functionality and safety over repeated use.
What regulatory pathway was followed for the Resmed S8 Pioneer CPAP System, and what does this mean for its use?
The Resmed S8 Pioneer CPAP System received FDA clearance through a 510(k) submission, specifically classified as a Class 2 Anesthesiology device under product code BZD. This means it has been determined to be substantially equivalent to a legally marketed device and is authorized for use in the United States under these regulatory guidelines.
Can the Resmed S8 Pioneer CPAP System be used in an MRI environment, and why?
No, the Resmed S8 Pioneer CPAP System is explicitly stated as not MRI-safe. This means it should not be used in or near an MRI machine, as the magnetic fields could potentially damage the device or pose safety risks.
What kind of maintenance or storage guidelines should be followed for the Resmed S8 Pioneer CPAP System?
The Resmed S8 Pioneer CPAP System requires proper storage and maintenance as outlined by the manufacturer to ensure functionality and hygiene. Since it is a reusable device, regular cleaning and upkeep are essential, and it should be stored in a clean, dry environment when not in use to prevent contamination or damage.
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 S8 Series II - ResMed, CPAP-Geräte, Masken, Zubehör und Ersatzteile | Resmed Shop, K041209 - RESMED S8 PIONEER CPAP SYSTEM | FDA 510 (k), Amazon.com: Resmed S8 Cpap Machine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041209 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K041209 24 fields · synced Sep 19, 2026