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Mirage Micro Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081321

by Resmed, Ltd.

Identifiers

510(k) Number
K081321 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 Mirage Micro Modification is a Ventilator, Non-Continuous (Respirator) designed to channel airflow non-invasively from a positive airway pressure (PAP) device, such as CPAP or bilevel systems, to a patient. It is classified under Anesthesiology and intended for use with adult patients weighing over 66 pounds (30 kg) who have been prescribed positive airway pressure therapy.

This device is supplied for single-patient reuse in the home environment and is intended for multi-patient use in clinical settings under controlled conditions. It is not sterile and is regulated under FDA 510(k) clearance (K081321) with a classification of Class II (BZD product code). No MRI safety information or specific storage requirements are provided in the regulatory data.

Frequently asked questions

What is the Mirage Micro Modification primarily used for and who is it intended for?

The Mirage Micro Modification is a non-invasive ventilator designed to channel airflow from positive airway pressure (PAP) devices, such as CPAP or bilevel systems, to patients. It is specifically intended for adult patients over 66 pounds (30 kg) who have been prescribed positive airway pressure therapy. This device is not meant for surgical or invasive ventilation but rather for non-continuous respiratory support in home or clinical settings.

Is the Mirage Micro Modification intended for single-use or reusable applications?

The Mirage Micro Modification is supplied for single-patient reuse in home environments, meaning it can be used by one patient at a time in a residential setting. However, it is also approved for multi-patient use in clinical settings under controlled conditions, allowing for shared use among multiple patients in a healthcare facility.

Are there any specific storage requirements mentioned for the Mirage Micro Modification?

The regulatory data for the Mirage Micro Modification does not provide any specific storage requirements. Users should follow general best practices for storing medical devices, such as keeping them in a clean, dry environment away from direct sunlight or extreme temperatures.

What regulatory pathway was followed for the approval of the Mirage Micro Modification?

The Mirage Micro Modification was cleared through the FDA’s 510(k) pathway, specifically under a Special Clearance type, and is classified as a Class II device with the product code BZD. This clearance was granted on October 9, 2008, and the device is intended for use in anesthesiology.

Does the Mirage Micro Modification come in different sizes or models, and if so, how are they differentiated?

The regulatory data lists multiple FEI numbers, which may correspond to different models or variations of the Mirage Micro Modification, but the provided description does not specify how these are differentiated in terms of size or functionality. For precise model details, such as sizing or specific features, refer to the manufacturer’s product documentation or contact Resmed directly.

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: MODIFICATION TO MIRAGE MICRO by RESMED LTD. | FDA 510(k) Summary, MODIFICATION TO MIRAGE MICRO (K081321) — FDA 510(k) | Innolitics, PDF K081321 MODIFICATION TO MIRAGE MICRO - 510kdatabase.net, MIRAGE MICRO by RESMED LTD. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Resmed, Ltd.

Sources (1)

  • FDA 510(k) K081321 24 fields · synced Sep 19, 2026