# K171765: Nihon Kohden CO2 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Oct 11, 2017 after 119 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: 5 generations back to K951127 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062115: Carbon Dioxide Monitor, Model Olg-2800A, Nihon Kohden America, Inc. (2006) Summary page 4.
- K093388: Smart Capnoline Guardian, Oridion Medical 1987, Ltd. (2010) Summary page 4.

## Recalls of this device
- Apr 29, 2022 · Class II · Z-0314-2025: Due to products being shipped/distributed to customers after the products expiration date had past.

## Indications for use
The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2. The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected. The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

Source page: https://510kreport.com/device/K171765
Methodology: https://510kreport.com/methodology