BiPAP AVAPS Ventilatory Support System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092818 FDA 510(k)
- FDA Product Code
- MNS 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 BiPAP AVAPS Ventilatory Support System is a non-invasive, continuous ventilator designed to provide ventilatory support. It features Average Volume Assured Pressure Support, which automatically adjusts pressure support to help patients maintain a target tidal volume.
This device is regulated as a Class 2 medical device under regulation number 868.5895 and has received FDA 510k clearance. It is intended for use as a non-life-supporting ventilator system.
Frequently asked questions
What is the primary function of the BiPAP AVAPS system?
The BiPAP AVAPS is a non-invasive, continuous ventilator designed to provide ventilatory support. It utilizes Average Volume Assured Pressure Support technology to automatically adjust pressure levels, helping patients maintain a consistent target tidal volume.
Is this device intended for life support?
No, the BiPAP AVAPS Ventilatory Support System is specifically intended for use as a non-life-supporting ventilator system.
What is the regulatory status of this device?
The BiPAP AVAPS is classified as a Class 2 medical device under regulation number 868.5895. It has received FDA 510k clearance, which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
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: RESPIRONICS BIPAP AVAPS USER MANUAL Pdf Download, PDF BiPAP AVAPS User manual, Respironics BIPAP AVAPS VENTILATOR from Progressive Home Medical, Respironics BiPAP AVAPS Service & Technical Information
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092818 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K092818 24 fields · synced Sep 22, 2026