# K131339: Capnomask

- Pathway: 510(k) (Traditional)
- Applicant: Mediplus, Ltd.
- Decided: Nov 25, 2013 after 200 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: 1 generation back to K971229 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. Environment of use - hospital and sub-acute settings. Patient population - Non-intubated patients who are breathing spontaneously.

Source page: https://510kreport.com/device/K131339
Methodology: https://510kreport.com/methodology