# K083456: Nihon Kohden CO2 Sensor Kit, Model TG-970P

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Mar 2, 2009 after 101 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: 4 generations back to K915494 (1993). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040875: Cap-One, Model TG-920P, Nihon Kohden America, Inc. (2004) Summary page 1.

## Most influential descendants
- K122214: TG-970P Sensor Kit W/ New Airway Adapter (YG-213T) (2013), 1 descendant of its own
- K243956: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (2025), 0 descendants of its own
- K161860: TG-970P CO2 Sensor Kit (2017), 0 descendants of its own

## Indications for use
The Nihon Kohden TG-970P Series CO 2 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.

Source page: https://510kreport.com/device/K083456
Methodology: https://510kreport.com/methodology