# K112546: O_Two Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: Dec 27, 2011 after 117 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862830 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093862: Carevent Handheld Cpap System, O-Two Medical Technologies, Inc. (2010) Summary page 1.
- K013884: Boussignac C.P.a.P. Device, Vygon SA (2003) Summary page 1.

## Indications for use
o-two OPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

Source page: https://510kreport.com/device/K112546
Methodology: https://510kreport.com/methodology