# K093862: Carevent Handheld Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: May 6, 2010 after 140 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: 4 generations back to K862830 (1986). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051469: Carevent Atv+ and Carevent Mri, O-Two Medical Technologies, Inc. (2005) Summary page 1.
- K080692: Macs Cpap System, Airon Corporation (2008) Summary page 1.
- K021520: Emt-Cpap, Emergency Medical Techology (2002) Summary page 1.

## Most influential descendants
- K112546: O_Two Cpap System (2011), 0 descendants of its own

## Indications for use
The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.

Source page: https://510kreport.com/device/K093862
Methodology: https://510kreport.com/methodology