# K062093: Avea Ventilator

- Pathway: 510(k) (Special)
- Applicant: Viasys Respiratory Care, Inc.
- Decided: Sep 20, 2006 after 58 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: 3 generations back to K902859 (1991). 13 ancestors in all.
21 later devices descend from it; 3 cite it directly.
10 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031745: Infant Flow Plus Infant Cpap System with Sipap Function, Sensor Medics Corp. (2004) Summary page 1.
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840), Puritan Bennett Corp. (1998) Summary page 1.

## Most influential descendants
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own
- K121225: Hamilton-C2 (2012), 8 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.

Source page: https://510kreport.com/device/K062093
Methodology: https://510kreport.com/methodology