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Inspiration Ventilator System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K051550

by eVent Medical, Ltd.

Identifiers

510(k) Number
K051550 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 is a continuous-use ventilator designed for facility-based respiratory support. Classified as a Class II device under the FDA’s medical specialty of anesthesiology, it provides mechanical ventilation to patients requiring assisted or controlled breathing, typically in critical care or operating room settings.

This system is intended for reusable application in hospital environments and is regulated under the FDA’s 510(k) pathway with a Special Clearance designation. It operates under the Medical Device Directive (MDD) and is assigned the product code CBK. The device is not single-use and requires proper maintenance, calibration, and storage as per manufacturer guidelines to ensure safety and functionality.

Frequently asked questions

Is the Inspiration Ventilator System designed for single-patient use or can it be reused in a hospital setting?

The Inspiration Ventilator System is explicitly intended for reusable application in hospital environments, as stated in the device description. It requires proper maintenance, calibration, and storage to ensure safety and functionality, which aligns with its classification as a reusable medical device for facility-based use.

What types of clinical settings is this ventilator primarily intended for, and how does that influence its use?

The Inspiration Ventilator System is designed for facility-based respiratory support, specifically in critical care or operating room settings. Its classification under the FDA’s anesthesiology specialty and its continuous-use design make it suitable for environments where patients require assisted or controlled breathing over extended periods, such as intensive care units or surgical suites.

How is the Inspiration Ventilator System regulated, and what does that mean for healthcare providers?

The device is regulated under the FDA’s 510(k) pathway with a Special Clearance designation and complies with the Medical Device Directive (MDD). This means it has undergone a review process to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for mechanical ventilation in facility-based settings. Healthcare providers must follow manufacturer guidelines for maintenance and calibration to comply with regulatory requirements.

Does the Inspiration Ventilator System come with specific models or sizes, and how might that affect patient compatibility?

While the provided data does not list explicit models or sizes of the Inspiration Ventilator System, it is classified as a continuous-use ventilator for facility-based respiratory support. Compatibility with patients would depend on the system’s adjustable parameters (e.g., pressure, volume, flow rates) and its ability to interface with various respiratory circuits and patient interfaces. For precise sizing or model-specific details, refer to the manufacturer’s technical documentation or consult their support team.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
eVent Medical, Ltd.

Sources (2)

  • FDA 510(k) K051550 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026