# K243956: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Jun 10, 2025 after 169 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: 5 generations back to K915494 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083456: Nihon Kohden CO2 Sensor Kit, Model TG-970P, Nihon Kohden America, Inc. (2009) Summary page 6.

## Indications for use
The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.

Source page: https://510kreport.com/device/K243956
Methodology: https://510kreport.com/methodology