# K991195: Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent Atv

- Pathway: 510(k) (Special)
- Applicant: O-Two Systems Intl., Inc.
- Decided: Apr 22, 1999 after 14 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
Longest line of descent: 2 generations back to K932170 (1993). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983643: Genesis BLS, O-Two Systems Intl., Inc. (1998) Summary page 1.
- K932170: Flynnr Genesis II a/C, a/O and Idlh, O-Two Systems Intl., Inc. (1993) Summary page 3.
- K983785: Autovent 1000, O-Two Systems Intl., Inc. (1998) Summary page 5.
- K983857: Autovent 1500, O-Two Systems Intl., Inc. (1998) Summary page 7.

## Most influential descendants
- K081330: Carevent Par (Public Access Resuscitator) (2009), 2 descendants of its own
- K141595: O-Two E700,O-Two E600,O-Two E500 (2015), 1 descendant of its own
- K113687: Equinox Relieve (2012), 1 descendant of its own
- K221634: Oxymag - Transport and Emergency Ventilator (2023), 0 descendants of its own
- K173205: Equinox Advantage (2018), 0 descendants of its own

## Indications for use
Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients. Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

Source page: https://510kreport.com/device/K991195
Methodology: https://510kreport.com/methodology