# K073069: Modification to Avea Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Respiratory Care, Inc.
- Decided: Jan 25, 2008 after 87 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 14 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962517 (1997). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982499: Cosmo Plus with Nico, Model 8200, Novametrix Medical Systems, Inc. (1998) Summary page 1.
- K022132: Servo Ventilator System, Model 64 87 800 E407E, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K963380: CO 2 Smo Plus, Novametrix Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K093094: Vela Ventilator (2010), 2 descendants of its own
- K101643: Model LTV 1100 Ventilator (2011), 1 descendant of its own
- K201082: LTV2 Series Ventilators (2021), 0 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

## 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/K073069
Methodology: https://510kreport.com/methodology