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Evolution 3E Ventilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113743

by Event Medical, Inc.

Identifiers

510(k) Number
K113743 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
SESE Substantially Equivalent FDA 510(k)

The Evolution 3E Ventilator is a continuous-use mechanical ventilator designed for facility-based critical care settings. It delivers controlled ventilation through precise pressure, flow, and volume regulation, supporting patients from neonatal to adult populations in intensive care environments.

This device is intended for facility use and has received FDA 510(k) clearance under the Anesthesiology advisory committee. It is classified as a Class II medical device (FDA code: 868.5895) and is supplied as a reusable system. The ventilator operates using Swiss pneumatic technology and requires maintenance by certified biomedical engineers or equivalent professionals. No MRI safety information or sterility specifications are provided in the data.

Frequently asked questions

What patient populations can the Evolution 3E Ventilator support, and how does it adjust ventilation parameters?

The Evolution 3E Ventilator is designed for facility-based critical care settings and supports patients from neonatal to adult populations. It delivers controlled ventilation through precise regulation of pressure, flow, and volume, ensuring tailored respiratory support across different patient sizes and needs.

Is the Evolution 3E Ventilator intended for single-use or reusable applications, and what maintenance is required?

The Evolution 3E Ventilator is supplied as a reusable system and requires regular maintenance by certified biomedical engineers or equivalent professionals. It operates using Swiss pneumatic technology, which necessitates specialized upkeep to ensure reliable performance in critical care environments.

How was the regulatory pathway for the Evolution 3E Ventilator determined, and what advisory committee was involved?

The Evolution 3E Ventilator received FDA 510(k) clearance under the Anesthesiology advisory committee, classified as a Class II medical device (FDA code: 868.5895). The clearance was granted through a traditional 510(k) review process, demonstrating substantial equivalence to a predicate device.

What types of facility settings is the Evolution 3E Ventilator intended for, and does it have any special compatibility considerations?

The ventilator is explicitly designed for facility-based critical care settings, such as intensive care units (ICUs), where continuous mechanical ventilation is required. While it does not specify MRI safety information, its Swiss pneumatic technology and reusable design are optimized for high-reliability environments where routine maintenance is feasible.

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: eVent Medical | Advanced Mechanical Ventilators for Critical Care, PDF Service Manual eVolution 3e - workshopbemshkl.com, eVolution 3e Ventilator - Medical XPRT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Event Medical, Inc.

Sources (1)

  • FDA 510(k) K113743 24 fields · synced Sep 19, 2026