# K022674: Bird Avea Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: Nov 6, 2002 after 86 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (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). 21 ancestors in all.
58 later devices descend from it; 3 cite it directly.
26 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013642: AVEA, Bird Products Corp. (2002) Summary page 2.
- (no number) DATEX-OHMEDA AESTIVA/5 with DATEX-OHMEDA 7100 Ventilator Anesthesia System: named in the summary without a submission number
- (no number) OHMEDA EXCEL 3000 Anesthesia Gas System: named in the summary without a submission number
- (no number) HOPE Nebulizer: named in the summary without a submission number

## Most influential descendants
- K041524: GE Datex-Ohmeda Heliox Delivery System (2004), 30 descendants of its own
- K060647: LTV 1200 Ventilator (2006), 29 descendants of its own
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), 28 descendants of its own
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), 12 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own

## Recalls of this device
- Dec 17, 2007 · Not classified · Z-0982-2008: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
- Dec 17, 2007 · Not classified · Z-0983-2008: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
- Dec 17, 2007 · Not classified · Z-0984-2008: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
- Dec 17, 2007 · Not classified · Z-0986-2008: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
- Dec 17, 2007 · Not classified · Z-0985-2008: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

## Indications for use
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).

Source page: https://510kreport.com/device/K022674
Methodology: https://510kreport.com/methodology