# K122214: TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: May 21, 2013 after 300 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 1.
- (no number) YG-211T: named in the summary without a submission number
- (no number) YG-211TW: named in the summary without a submission number

## Most influential descendants
- K161860: TG-970P CO2 Sensor Kit (2017), 0 descendants of its own

## Indications for use
The Nihon Kohden TG-970P and 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 or clinical environment and is available for use on any patient weighing 2kg or more.

Source page: https://510kreport.com/device/K122214
Methodology: https://510kreport.com/methodology