Identifiers
- 510(k) Number
- K132887 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 AirFit N10 is a nasal mask designed for use with non-continuous ventilators (respirators) and continuous positive airway pressure (CPAP) devices. It provides respiratory support by delivering pressurized air through the nasal passages, aiding patients with conditions such as obstructive sleep apnea or other respiratory disorders requiring ventilatory assistance. Its design focuses on minimizing pressure points and maximizing comfort during prolonged use.
This device is intended for single-use or reusable applications in clinical and home settings, depending on facility protocols. Supplied as a reusable nasal mask with adjustable headgear, it is not sterile at the time of shipment and must be cleaned and maintained according to manufacturer guidelines. The AirFit N10 is classified as a Class II medical device under FDA regulations (21 CFR 868.5905) and has received FDA 510(k) clearance through a traditional review process. It is intended for use with compatible ventilators and CPAP machines, adhering to MRI safety standards for non-ferromagnetic materials.
Frequently asked questions
What is the AirFit N10 nasal mask used for?
The AirFit N10 nasal mask is designed to provide respiratory support by delivering pressurized air through the nasal passages. It is intended for use with non-continuous ventilators (respirators) and continuous positive airway pressure (CPAP) devices, helping patients with conditions such as obstructive sleep apnea or other respiratory disorders requiring ventilatory assistance.
Is the AirFit N10 nasal mask reusable or single-use?
The AirFit N10 nasal mask is supplied as a reusable device. It is not sterile at the time of shipment and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper hygiene and functionality. Facilities can choose to reuse it following their established protocols.
How is the AirFit N10 nasal mask compatible with ventilators and CPAP machines?
The AirFit N10 is specifically designed to work with compatible non-continuous ventilators and CPAP devices. It adheres to MRI safety standards for non-ferromagnetic materials, ensuring it can be safely used in environments where MRI scans may be required. Always verify compatibility with your specific device before use.
What are the key features of the AirFit N10 nasal mask?
The AirFit N10 nasal mask is engineered to minimize pressure points and maximize comfort during prolonged use. It includes adjustable headgear to accommodate different facial structures, ensuring a secure and comfortable fit for patients requiring extended respiratory support.
How should the AirFit N10 nasal mask be stored?
Since the AirFit N10 is not sterile at shipment, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for cleaning and maintenance to preserve its integrity and ensure safe reuse. Proper storage helps maintain the mask’s functionality and hygiene.
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: ResMed AirFit™ N10 Nasal CPAP / BiPAP Mask with Headgear, PDF AirFit N10 - ResMed, AirFit P30i Nasenpolstermaske CPAP | Resmed Deutschland, PDF AirFit N10 - ResMed, AirFit N20 Nasenmaske für PAP- und Beatmungsgeräte | Resmed …
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132887 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K132887 24 fields · synced Oct 1, 2026