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Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131901

by 3B Medical, Inc.

Identifiers

510(k) Number
K131901 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 Ivolve Nasal Mask, Ivolve Full Face Mask, and Ivolve N2 are ventilator interfaces designed for non-continuous respiratory support. These devices deliver airflow from positive pressure ventilation systems to the patient’s nose or mouth, ensuring effective gas exchange during anesthesia or mechanical ventilation. The nasal mask targets nasal airflow, while the full-face mask provides broader coverage for oral or nasal breathing, and the Ivolve N2 is optimized for specific ventilatory needs. Each mask is engineered to minimize leaks and enhance patient comfort during use.

The Ivolve masks are supplied sterile and intended for single-use, adhering to Class II regulatory standards under FDA 510(k) clearance (K131901). They are secured to the patient’s face using adjustable headgear and are compatible with non-continuous ventilators. The devices are classified under product code BZD and regulated under FDA regulation 868.5905, with an advisory committee designation for anesthesiology. Storage instructions and MRI safety are not specified in the available data.

Frequently asked questions

What is the Ivolve mask system used for?

The Ivolve Nasal Mask, Ivolve Full Face Mask, and Ivolve N2 are ventilator interfaces designed to deliver airflow from positive pressure ventilation systems to the patient’s nose or mouth during non-continuous respiratory support, such as anesthesia or mechanical ventilation, to ensure effective gas exchange.

Are the Ivolve masks sterile and single-use?

Yes, the Ivolve masks are supplied sterile and intended for single-use only, as indicated in the device description, to reduce the risk of cross-contamination and ensure patient safety during each use.

How are the Ivolve masks secured to the patient?

The Ivolve masks are secured to the patient’s face using adjustable headgear, which allows for a customized fit to minimize leaks and enhance comfort during ventilation therapy.

What type of ventilators are the Ivolve masks compatible with?

The Ivolve masks are compatible with non-continuous ventilators, as specified in the device description, meaning they are designed for use with ventilation systems that deliver breaths intermittently rather than continuously.

What regulatory pathway was used for the Ivolve masks?

The Ivolve Nasal Mask, Ivolve Full Face Mask, and Ivolve N2 received FDA 510(k) clearance under submission number K131901, demonstrating substantial equivalence 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: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2, K131901 FDA 510 (k) - IVOLVE NASAL MASK | 3B Medical, Inc., IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 510 (k) K131901 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3B Medical, Inc.

Sources (1)

  • FDA 510(k) K131901 24 fields · synced Oct 1, 2026