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VPAP Malibu with H2I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062291

by Resmed, Ltd.

Identifiers

510(k) Number
K062291 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 Malibu with H2I is a non-continuous ventilator designed for respiratory support. Classified as a ventilator under FDA category BZD, it provides pressure-assisted ventilation for patients with obstructive sleep apnea (OSA) or other respiratory conditions requiring intermittent positive pressure support. Its adaptive algorithms adjust pressure delivery to enhance patient comfort and efficacy during use.

This device is intended for both hospital and home use, delivering pressure support via an integrated humidifier (H2I) to reduce airway irritation. Supplied as a reusable medical device, it requires proper cleaning and maintenance per manufacturer guidelines. The VPAP Malibu with H2I holds FDA 510(k) clearance (K062291) and adheres to regulatory standards for ventilators under 21 CFR 868.5905, ensuring compliance with safety and performance requirements for respiratory therapy applications.

Frequently asked questions

What is the VPAP Malibu with H2I used for?

The VPAP Malibu with H2I is a non-continuous ventilator designed to provide pressure-assisted ventilation for patients with obstructive sleep apnea (OSA) or other respiratory conditions requiring intermittent positive pressure support. Its adaptive algorithms adjust pressure delivery to improve patient comfort and effectiveness during use, making it suitable for both hospital and home environments.

Is the VPAP Malibu with H2I a single-use or reusable device?

The VPAP Malibu with H2I is a reusable medical device. It requires proper cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure safe and effective operation over multiple uses.

Does this device include a humidifier, and what is its purpose?

Yes, the VPAP Malibu with H2I features an integrated humidifier (H2I) that delivers moisture to the air during ventilation. This helps reduce airway irritation, improving patient comfort and adherence to therapy, particularly for those with dry nasal passages or respiratory conditions.

What regulatory clearance does the VPAP Malibu with H2I hold?

The VPAP Malibu with H2I holds FDA 510(k) clearance (K062291) and is classified under FDA category BZD for ventilators. It complies with regulatory standards outlined in 21 CFR 868.5905, ensuring it meets safety and performance requirements for respiratory therapy applications.

How is the device supplied, and what should be considered for storage?

The VPAP Malibu with H2I is supplied as a reusable device, meaning it is intended for repeated use after proper cleaning and maintenance. Storage should follow manufacturer instructions to preserve functionality, including protection from moisture, extreme temperatures, and physical damage. Always store in a clean, dry environment when not in use.

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: RESMED VPAP MALIBU USER MANUAL Pdf Download | ManualsLib, Resmed VPAP Malibu Manuals | ManualsLib, ResMed VPAP Malibu User Guide | Manualzz, VPAP MALIBU WITH H2I (K062291) — FDA 510 (k) | Innolitics, ResMed Malibu Item 26201 - CPAP Success 4u

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Resmed, Ltd.

Sources (1)

  • FDA 510(k) K062291 24 fields · synced Oct 1, 2026