# K251641: GF-310R Multigas Unit (GF-310R)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Aug 12, 2026 after 440 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: 7 generations back to K946306 (1995). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110594: GF-210R Multi-Gas Module for Nohon Kohden Bedside Monitors, Nihon Kohden Corp. (2011) Summary page 6.

## Indications for use
The GF-310R Multigas Unit is intended to measure carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and following anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a Nihon Kohden bedside monitor. The GF-310R can measure two anesthetic agents simultaneously. The GF-310R 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/K251641
Methodology: https://510kreport.com/methodology