# K223120: Ventoux VC2; Ventoux VC3

- Pathway: 510(k) (Traditional)
- Applicant: Flight Medical Innovations, Ltd.
- Decided: Dec 2, 2024 after 791 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 78 ancestors in all.
No later device cites it as a predicate yet.
5 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143035: Flight 60 Ventilator, Flight Medical Innovations, Ltd. (2016) Summary page 6.

## Indications for use
The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs). The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

Source page: https://510kreport.com/device/K223120
Methodology: https://510kreport.com/methodology