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Galileo Ventilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001686

by Hamilton Medical, Inc.

Identifiers

510(k) Number
K001686 FDA 510(k)
FDA Product Code
CBK 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
ST FDA 510(k)

The Galileo Ventilator is a continuous-use, facility-based mechanical ventilator designed for invasive and noninvasive ventilation in adult, pediatric, and infant patients. It supports a range of ventilation modes, including advanced and closed-loop modalities, with features such as tube resistance compensation.

This device is intended for use in intensive care settings and is supplied as a reusable medical device. It is regulated under FDA 510(k) clearance (K001686) and falls under the Anesthesiology advisory committee classification. The ventilator operates in environments requiring strict sterility protocols and is subject to facility-based maintenance and calibration.

Frequently asked questions

What patient populations can the Galileo Ventilator support, and how does it differ in its ventilation capabilities for each group?

The Galileo Ventilator is designed for invasive and noninvasive ventilation across three patient populations: adults, pediatrics, and infants. Its advanced ventilation modes, including closed-loop and tube resistance compensation, allow for precise adjustments to meet the varying respiratory needs of each group, ensuring tailored support for critical care settings.

Is the Galileo Ventilator intended for single-use or reusable applications, and what maintenance protocols must facilities follow?

The Galileo Ventilator is a reusable medical device, meaning it is not designed for single-use. Since it operates in environments requiring strict sterility protocols, facilities must adhere to facility-based maintenance and calibration procedures to ensure proper functionality and compliance with regulatory standards.

What regulatory pathway was followed for the Galileo Ventilator’s FDA clearance, and how does this affect its use in clinical settings?

The Galileo Ventilator received FDA 510(k) clearance (K001686) under an abbreviated review and is classified under the Anesthesiology advisory committee. This clearance indicates it is deemed substantially equivalent to a predicate device, allowing its use in intensive care settings for invasive and noninvasive ventilation while adhering to FDA-mandated safety and performance requirements.

Does the Galileo Ventilator support specialized ventilation modes, and if so, what are some of its key features?

Yes, the Galileo Ventilator supports a range of ventilation modes, including advanced and closed-loop modalities. One of its key features is tube resistance compensation, which helps optimize ventilation efficiency by accounting for resistance in airway tubes, improving patient outcomes in critical care scenarios.

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: Hamilton Medical - Galileo Community, Manuals and Specifications ..., GALILEO training | Hamilton Medical, GALILEO intensive care ventilator - Respiratory Therapy

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hamilton Medical, Inc.

Sources (1)

  • FDA 510(k) K001686 24 fields · synced Sep 20, 2026