# K170820: Capnograph and Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Cmi Health, Inc.
- Decided: Jul 18, 2018 after 485 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: 11 generations back to K962603 (1997). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 43 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093016: Vital Signs Monitor, Shenzhen Creative Industry Co., Ltd. (2010) Summary page 5.

## Most influential descendants
- K192488: CO2 Sidestream Module (2020), 0 descendants of its own

## Indications for use
The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate. The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel

Source page: https://510kreport.com/device/K170820
Methodology: https://510kreport.com/methodology