# K110594: GF-210R Multi-Gas Module for Nohon Kohden Bedside Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Oct 28, 2011 after 240 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: 6 generations back to K946306 (1995). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020046: Multigas Unit, Model AG-920RA, Nihon Kohden America, Inc. (2002) Summary page 1.
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module, Draeger Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K251641: GF-310R Multigas Unit (GF-310R) (2026), 0 descendants of its own

## Indications for use
The Nihon Kohden GR-2 1OR Multi-Gas Module is intended to measure carbon dioxide (C0 2 ), nitrous oxide (N 2 0), oxygen (02), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desfiurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-210OR can measure two anesthetic agents simultaneously. The system is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patients as determined by the qualified medical personnel..

Source page: https://510kreport.com/device/K110594
Methodology: https://510kreport.com/methodology