# K081837: Avea Ventilator

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 207, Inc.
- Decided: Aug 13, 2008 after 44 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: 5 generations back to K902859 (1991). 22 ancestors in all.
13 later devices descend from it; 2 cite it directly.
8 of 36 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 1.
- K990949: Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port, Intersurgical, Inc. (1999) Summary page 1.

## Most influential descendants
- K092847: 840 Ventilator System with Expanded Neomode Option (2010), 11 descendants of its own
- K151252: Puritan Bennett 840 Series Ventilator System (2016), 7 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K131252: Puritan Bennett 980 Series Ventilator System (2014), 2 descendants of its own

## Indications for use
The AVEA Ventilator 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 be operated by properly trained clinical personnel, under the direction of a physician. This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use.

Source page: https://510kreport.com/device/K081837
Methodology: https://510kreport.com/methodology