# K013642: AVEA

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: May 22, 2002 after 198 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 19 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902859 (1991). 20 ancestors in all.
133 later devices descend from it; 5 cite it directly.
42 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 2.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 2.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 2.
- K992788: Bear Cub 750 PSV, Bear Medical Systems, Inc. (1999) Summary page 2.
- K983981: Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET Tube, Bear Medical Systems, Inc. (1998) Summary page 2.
- K993449: Bird V.I.P. Gold/Sterling, Bird Products Corp. (1999) Summary page 2.
- K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator, Datex-Ohmeda, Inc. (2000)

## 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

## Recalls of this device
- May 17, 2016 · Class I · Z-1888-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1895-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1896-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1899-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1892-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1897-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1898-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1894-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1889-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1891-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1890-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- May 17, 2016 · Class I · Z-1893-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing
- Sep 5, 2013 · Class I · Z-2273-2013: CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. Ca
- Sep 8, 2011 · Not classified · Z-0510-2012: The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011
- 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.

Source page: https://510kreport.com/device/K013642
Methodology: https://510kreport.com/methodology