# K251133: AVEA disposable expiratory filter/water trap (11790)

- Pathway: 510(k) (Traditional)
- Applicant: Telesair, Inc.
- Decided: May 8, 2025 after 27 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: 6 generations back to K902859 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081837: Avea Ventilator, Cardinal Health 207, Inc. (2008) Summary page 6.

## Indications for use
The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator. It would be used in an institutional healthcare 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.

Source page: https://510kreport.com/device/K251133
Methodology: https://510kreport.com/methodology