# K051469: Carevent Atv+ and Carevent Mri

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: Sep 28, 2005 after 117 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.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093862: Carevent Handheld Cpap System (2010), 1 descendant of its own
- K123957: Pneupac Parapac Plus (2013), 0 descendants of its own
- K112546: O_Two Cpap System (2011), 0 descendants of its own

## Indications for use
The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport. They are designed to be used by suitably trained medical personnel in the pre-hospital, Intra-hospital, inter-hospital and air ambulance settings. In addition CAREvent MRI is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure. The ventilator is suitable for use in: * Pulmonary resuscitation during respiratory and/or cardiac arrest. * Short term ventilatory support in the pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients. * In addition CAREvent MRI only is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.

Source page: https://510kreport.com/device/K051469
Methodology: https://510kreport.com/methodology