# K032451: Bird Tbird Vela Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: Mar 17, 2004 after 219 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 30 ancestors in all.
114 later devices descend from it; 7 cite it directly.
40 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020746: Bird Tbird Vela Ventilator, Bird Products Corp. (2002) Summary page 1.
- K013642: AVEA, Bird Products Corp. (2002) Summary page 1.
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.

## Most influential descendants
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own

## Recalls of this device
- Jan 31, 2007 · Not classified · Z-0638-2007: The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.

## Indications for use
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician: * Positive pressure ventilation * Assist/Control, SIMV, CPAP modes of ventilation The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.

Source page: https://510kreport.com/device/K032451
Methodology: https://510kreport.com/methodology