Facefit and Facefit Ported Non-invasive Ventilation Masks
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121747 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 Facefit and Facefit Ported Non-invasive Ventilation Masks are medical devices designed for use in non-invasive ventilation. These masks are available in two configurations, including a sealed version for conventional ventilation and a ported version for use with bilevel and CPAP applications.
These single-use adult hospital masks are available in small, medium, and large sizes. The ported model includes an anti-asphyxiation valve and a CO2 leak port for specific ventilation requirements. This device is authorized under FDA 510K clearance.
Frequently asked questions
What are the Facefit and Facefit Ported masks used for?
These masks are designed for use in non-invasive ventilation. The sealed version is intended for conventional ventilation, while the ported version is specifically designed for use with bilevel and CPAP applications.
Are these masks intended for single-use or can they be reused?
These are single-use adult hospital masks. They are designed to be used once to ensure patient safety and hygiene standards within a clinical environment.
What sizes are available for these masks?
The Facefit and Facefit Ported masks are available in three sizes: small, medium, and large, to accommodate different adult patient requirements.
What is the difference between the standard and ported models?
The standard model is a sealed version for conventional ventilation. The ported model includes an anti-asphyxiation valve and a CO2 leak port to meet specific ventilation requirements for bilevel and CPAP applications.
What is the regulatory status of these devices?
These devices are authorized under FDA 510K clearance, which indicates they have been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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 FaceFit and FaceFit ported - Intersurgical, Facefit and Facefit Ported Non-invasive Ventilation Masks, Intersurgical - FaceFit™ NIV ported mask
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121747 | Class II | Active |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA 510(k) K121747 24 fields · synced Sep 25, 2026