# K020746: Bird Tbird Vela Ventilator

- Pathway: 510(k) (Special)
- Applicant: Bird Products Corp.
- Decided: Apr 22, 2002 after 46 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: 2 generations back to K883038 (1988). 7 ancestors in all.
120 later devices descend from it; 2 cite it directly.
38 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950484: Tbird VS Ventilator and Tbird Avs Ventilator, Bird Products Corp. (1996) Summary page 1.
- K920113: Bird Graphics Monitor, Bird Products Corp. (1993) Summary page 1.
- K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer, Bird Products Corp. (1998) Summary page 1.
- K911336: Bird Nebulization Synchronizer, Bird Products Corp. (1991) Summary page 1.

## Most influential descendants
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- 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

## 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 Ibs.), who require the following general types of ventilatory support, as prescribed by an attending physician: o Positive pressure ventilation e 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/K020746
Methodology: https://510kreport.com/methodology