# K093094: Vela Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health 207, Inc.
- Decided: May 11, 2010 after 222 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: 7 generations back to K902859 (1991). 49 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022132: Servo Ventilator System, Model 64 87 800 E407E, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 1.
- K073069: Modification to Avea Ventilator, Viasys Respiratory Care, Inc. (2008) Summary page 3.

## Most influential descendants
- K101643: Model LTV 1100 Ventilator (2011), 1 descendant of its own
- K201082: LTV2 Series Ventilators (2021), 0 descendants of its own

## Indications for use
The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11Ib), who require the following types of ventilation support, as prescribed by an attending physician. - Positive pressure ventilation - Assist / control, SIMV, or CPAP modes of ventilation The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.

Source page: https://510kreport.com/device/K093094
Methodology: https://510kreport.com/methodology