# K051889: Carevent CA and Dra

- Pathway: 510(k) (Special)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: Aug 30, 2005 after 49 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators used to provide ventilatory support to normal adults in confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment. The ventilator is suitable for use in: * Pulmonary resuscitation during respiratory and/or cardiac arrest. * Short term ventilatory support in the confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients.

Source page: https://510kreport.com/device/K051889
Methodology: https://510kreport.com/methodology