Identifiers
- 510(k) Number
- K161978 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 N20 Nasal Mask is a non-continuous ventilator designed for use in anesthesia and respiratory support. It delivers pressurized air to the nasal passages, providing continuous positive airway pressure (CPAP) to maintain an open airway during sleep or medical procedures.
This device is intended for single-use and is supplied as a complete mask system, including frames, headgear, and cushions. It is classified as a Class II medical device under FDA regulations (868.5905) and has received FDA 510(k) clearance as substantially equivalent. The mask is compatible with various CPAP and ventilation devices and is intended for use in clinical settings where airway management is required.
Frequently asked questions
What clinical scenarios is the AirFit N20 Nasal Mask primarily designed for, and how does it differ from standard CPAP masks?
The AirFit N20 Nasal Mask is specifically designed for anesthesia and respiratory support during medical procedures or sleep, delivering continuous positive airway pressure (CPAP) to maintain an open airway. Unlike standard CPAP masks, it is classified as a non-continuous ventilator, meaning it is intended for use with ventilatory devices in clinical settings where precise airway management is required, such as in operating rooms or intensive care units.
Is the AirFit N20 Nasal Mask reusable, or is it intended for single-use only? How does this affect its clinical workflow?
The AirFit N20 Nasal Mask is intended for single-use only, as explicitly stated in its design. This ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflows, as each mask can be discarded after a single procedure or patient session without the need for sterilization or reprocessing.
What components are included in the complete AirFit N20 Nasal Mask system, and how is it typically supplied?
The AirFit N20 Nasal Mask is supplied as a complete mask system, including the nasal mask frames, headgear, and cushions. This ensures all necessary components for proper fit and functionality are provided out-of-the-box, reducing the need for additional accessories during use.
What regulatory pathway was followed for FDA clearance of the AirFit N20 Nasal Mask, and which advisory committee was involved?
The AirFit N20 Nasal Mask received FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision code of SESE (Substantially Equivalent). The Anesthesiology (AN) Advisory Committee was involved in reviewing the submission, reflecting its specialized use in airway management during anesthesia procedures.
Does the AirFit N20 Nasal Mask come in multiple sizes or models, and if so, how would a clinician determine the appropriate fit for a patient?
While the provided data does not explicitly list individual sizes or models, the AirFit N20 is designed as a nasal mask system with adjustable components (frames, cushions, and headgear) to accommodate various patient anatomies. Clinicians would typically rely on manufacturer guidelines or sizing charts to select the appropriate fit, ensuring proper sealing and comfort for effective CPAP delivery.
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: AirFit N20 CPAP nasal mask | Resmed, Getting started with AirFit N20 mask & Air10 machine | Resmed, AirFit N20 CPAP Masks, Frames, Headgear & Cushions | Resmed Shop, AirFit N20 Complete Mask System | Resmed Shop, AirFit N20 nasal mask for CPAP and ventilation devices - ResMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161978 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K161978 24 fields · synced Sep 19, 2026