← Back to catalogue

Ventoux VC2; Ventoux VC3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223120

by Flight Medical Innovations Ltd

Identifiers

510(k) Number
K223120 FDA 510(k)
FDA Product Code
CBK FDA 510(k)
Models / Variants
Ventoux VC2 FDA 510(k)
Ventoux VC3 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 Ventoux VC2 and VC3 are continuous facility-use ventilators designed for mechanical ventilation support in adult and pediatric patients. These devices provide both continuous and intermittent ventilation, delivering controlled respiratory assistance in clinical settings where advanced respiratory care is required.

The Ventoux VC2 and VC3 are intended for facility-based use, supplied as reusable medical devices, and comply with FDA 510(k) clearance under regulation 868.5895. They are classified as Class II devices and authorized for use in anesthesiology settings. No specific sterility or MRI safety information is provided in the data.

Frequently asked questions

Are the Ventoux VC2 and VC3 ventilators intended for use in home settings or only in clinical facilities?

The Ventoux VC2 and VC3 are explicitly designed for facility-use only, meaning they are intended for clinical settings like hospitals or operating rooms where advanced respiratory support is required. They are not approved for home or portable use.

How are the Ventoux VC2 and VC3 ventilators supplied, and are they single-use or reusable?

The Ventoux VC2 and VC3 are reusable medical devices, meaning they are not designed for single-use. They are intended to be cleaned, maintained, and reused within a clinical facility following proper protocols.

What regulatory pathway was followed for FDA clearance of the Ventoux VC2 and VC3 ventilators?

The Ventoux VC2 and VC3 received FDA 510(k) clearance through a traditional review process, classified as Class II devices under regulation 868.5895. The submission was reviewed by the Anesthesiology (AN) Advisory Committee and determined to be substantially equivalent to a predicate device.

Are there any specific size or model variations available for the Ventoux VC2 and VC3 ventilators?

The data provided does not specify distinct size or model variations beyond the two primary models (VC2 and VC3). Both are designed for adult and pediatric patients in facility-based settings, but no additional sub-variations (e.g., pediatric-specific adjustments) are mentioned.

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: VENTOUX - FlightMedical, Ventoux VC2; Ventoux VC3 by Flight Medical Innovations Ltd. | FDA 510 ..., Ventoux VC2; Ventoux VC3 510 (k) K223120 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Flight Medical Innovations Ltd
FDA Applicant
Flight Medical Innovations , Ltd.

Sources (1)

  • FDA 510(k) K223120 24 fields · synced Sep 20, 2026