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Inspiration Ventilator System 5I/7I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130178

by eVent Medical, Ltd.

Identifiers

510(k) Number
K130178 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 Inspiration Ventilator System 5I/7I is a continuous-use ventilator designed for facility-based respiratory support. Classified as a Class II device, it provides mechanical ventilation for patients requiring assisted or controlled breathing, including those in critical care settings such as anesthesia and intensive care units.

This system is intended for facility use and has received FDA 510(k) clearance under the Anesthesiology advisory committee. The device is supplied as a reusable medical instrument, with technical specifications tailored for clinical environments. It adheres to regulatory standards outlined in 21 CFR 868.5895 and is intended for use in controlled settings where continuous monitoring and ventilation are required.

Frequently asked questions

What is the Inspiration Ventilator System 5I/7I intended for?

The Inspiration Ventilator System 5I/7I is a continuous-use ventilator designed for facility-based respiratory support, providing mechanical ventilation for patients requiring assisted or controlled breathing in critical care settings such as anesthesia and intensive care units.

Is the Inspiration Ventilator System 5I/7I a reusable or single-use device?

The device is supplied as a reusable medical instrument, meaning it is designed for multiple uses after appropriate cleaning, disinfection, and maintenance in accordance with the manufacturer's instructions.

What regulatory pathway was used for the Inspiration Ventilator System 5I/7I?

The Inspiration Ventilator System 5I/7I received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device under the traditional 510(k) process.

Under which regulation is the Inspiration Ventilator System 5I/7I classified?

The device adheres to regulatory standards outlined in 21 CFR 868.5895, which governs continuous ventilators for facility use, and is classified as a Class II medical device.

What advisory committee reviewed the Inspiration Ventilator System 5I/7I during its FDA submission?

The device was reviewed under the Anesthesiology advisory committee, as indicated in the FDA 510(k) submission data, which reflects the clinical specialty associated with its intended use in anesthesia and critical care settings.

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, eVENT Medical - Inspiration 5i Community, Manuals and Specifications ..., PDF Inspiration 5i/7i Ventilator System - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
eVent Medical, Ltd.

Sources (1)

  • FDA 510(k) K130178 24 fields · synced Sep 19, 2026