Astral Ventilator
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K133868 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Astral Ventilator is a continuous ventilator for facility use, providing both invasive and non-invasive ventilation. It is designed for patients weighing over 5kg who require acute and/or long-term care, offering various modes, circuits, and interfaces to treat a wide range of conditions.
The ventilator features simple yet sophisticated technologies including Resmed iVAPS™ 3 with optional AutoEPAP 4, and offers remote patient monitoring capabilities. It is supplied with wireless connectivity and has received FDA 510(k) clearance with the product code CBK, classified as a Class II device under regulation number 868.5895.
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: Astral respiratory ventilators | Resmed, Astral portable ventilator for IV and NIV | Resmed, Astral life support ventilators | ResMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133868 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K133868 24 fields · synced Sep 22, 2026