# K171235: OmniCap

- Pathway: 510(k) (Traditional)
- Applicant: Respirion, Inc.
- Decided: Jan 4, 2018 after 252 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 K981114 (1998). 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)
- K981114: Microcap, Oridion Medical, Ltd. (1998) Summary page 4.

## Indications for use
The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider. Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.

Source page: https://510kreport.com/device/K171235
Methodology: https://510kreport.com/methodology