Identifiers
- 510(k) Number
- K160836 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 Menai System is a Ventilator, Non-Continuous (Respirator) designed for use in anesthesia applications. It provides mechanical ventilation to patients during surgical or procedural procedures, delivering controlled airflow via a non-invasive interface. The device is classified as a Class II medical device under FDA regulations and is intended for use in clinical settings where respiratory support is required.
The Menai System is supplied as a standalone ventilator accessory compatible with ResMed respiratory devices, including CPAP systems. It is intended for single-use or reusable configurations depending on the associated mask components (e.g., full-face masks). The system operates under FDA clearance (K160836) and adheres to regulatory standards outlined in 21 CFR 868.5905, with no specific MRI safety restrictions noted. Storage and handling follow standard medical device protocols to ensure sterility and functionality.
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: Menai System (K160836) — FDA 510 (k) | Innolitics, Menai System — FDA 510 (k) K160836 | MedTracker, Menai System 510 (k) K160836 - FDA.report, Menai mask (full face) and Menai Standard mask (full face) and Menai ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160836 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K160836 24 fields · synced Oct 1, 2026