VPAP Auto with HumidAire 3I
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K082605 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 VPAP Auto with HumidAire 3I is a non-continuous ventilator (respirator) designed for use in anesthesia and respiratory support. It delivers variable positive airway pressure (VPAP) to assist or control ventilation in patients, adjusting pressure levels automatically to meet respiratory needs. The integrated HumidAire 3I provides heated humidification to reduce airway irritation and improve patient comfort during prolonged use.
This device is intended for use in clinical settings, including operating rooms and recovery areas, where precise respiratory support is required. Supplied as a reusable medical device, it requires regular maintenance and calibration as per manufacturer guidelines. The HumidAire 3I component is designed for single-use or reusable application, depending on clinical protocols, and must be handled according to sterile procedures when applicable. The VPAP Auto with HumidAire 3I holds an FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for non-invasive ventilation systems.
Frequently asked questions
What is the VPAP Auto with HumidAire 3I used for?
The VPAP Auto with HumidAire 3I is a non-continuous ventilator (respirator) designed specifically for anesthesia and respiratory support in clinical settings. It provides variable positive airway pressure (VPAP) to assist or control ventilation, automatically adjusting pressure levels to meet a patient’s respiratory needs. The integrated HumidAire 3I component adds heated humidification, which helps minimize airway irritation and enhances comfort during prolonged use, making it ideal for operating rooms and recovery areas.
Is the VPAP Auto with HumidAire 3I a reusable or single-use device?
The VPAP Auto ventilator itself is a reusable medical device, requiring regular maintenance and calibration as outlined by the manufacturer. The HumidAire 3I component, however, can be used either as a single-use or reusable item, depending on clinical protocols. When used in sterile procedures, it must be handled according to sterile techniques to ensure patient safety.
How does the HumidAire 3I component improve patient care?
The HumidAire 3I component provides heated humidification, which helps reduce airway irritation and dryness that can occur during prolonged ventilation. By maintaining moisture levels in the airway, it improves patient comfort and may reduce complications associated with dry air, particularly during extended procedures or recovery periods in anesthesia settings.
What regulatory clearance does the VPAP Auto with HumidAire 3I hold?
The VPAP Auto with HumidAire 3I holds an FDA 510(k) clearance, classifying it as a Class II medical device. This clearance confirms that the device meets regulatory standards for non-invasive ventilation systems and is substantially equivalent to a legally marketed predicate device, as determined by the FDA’s Anesthesiology Advisory Committee.
What maintenance is required for the VPAP Auto with HumidAire 3I?
Since the VPAP Auto ventilator is reusable, it requires regular maintenance and calibration to ensure accurate performance and safety. The manufacturer provides specific guidelines for cleaning, servicing, and inspecting the device, which must be followed to maintain compliance with clinical standards and regulatory requirements. The HumidAire 3I component may also require cleaning or replacement based on clinical protocols and sterility needs.
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 VPAPTM Auto - ResMed, RESMED VPAP AUTO USER MANUAL Pdf Download | ManualsLib, RESMED VPAP AUTO MANUAL Pdf Download | ManualsLib, ResMed Compact Bilevel Device VPAP Auto User Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082605 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K082605 24 fields · synced Oct 1, 2026