# K222511: Oxy2Pro

- Pathway: 510(k) (Traditional)
- Applicant: Southmedic, Inc.
- Decided: Nov 21, 2023 after 459 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971229 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172365: Panoramic Oxygen Mask (POM), Pom Medical, LLC (2018) Summary page 5.

## Indications for use
Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, or tubes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for non-intubated, adult patients who are breathing spontaneously.

Source page: https://510kreport.com/device/K222511
Methodology: https://510kreport.com/methodology