# K143035: Flight 60 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Flight Medical Innovations, Ltd.
- Decided: Mar 30, 2016 after 525 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: 14 generations back to K902859 (1991). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130171: Flight 60 Ventilator, Flight Medical Innovations, Ltd. (2014) Summary page 5.
- K083526: Trilogy 100 Ventilator, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 5.

## Most influential descendants
- K223120: Ventoux VC2; Ventoux VC3 (2024), 0 descendants of its own

## Indications for use
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs). The FLIGHT 60 Ventilator 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, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Source page: https://510kreport.com/device/K143035
Methodology: https://510kreport.com/methodology