# K014211: Oxyarm CO2

- Pathway: 510(k) (Traditional)
- Applicant: Southmedic, Inc.
- Decided: Jun 11, 2002 after 172 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942907 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971229: Capnoxygen Mask, Medsys, Inc. (1997) Summary page 1.
- K942907: Jemsdal Mask, Respan Products, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K001865: Southmedic - OxyArm oxygen. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Recalls of this device
- Oct 17, 2017 · Class II · Z-1288-2018: Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

## Indications for use
To deliver oxygen to patients in low to medium concentrations and provides a means to sample expired gases

Source page: https://510kreport.com/device/K014211
Methodology: https://510kreport.com/methodology