# K990063: Nihon Kohden TG-901T CO2 Sensor Kit with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jun 9, 1999 after 152 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: 2 generations back to K915494 (1993). 2 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964305: Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories, Nihon Kohden America, Inc. (1997) Summary page 1.

## Most influential descendants
- K040875: Cap-One, Model TG-920P (2004), 13 descendants of its own
- K050833: Electrode Junction Box, Model JE-921A (2005), 7 descendants of its own
- K120888: PSG-1100 Sleep Diagnostic System (2012), 6 descendants of its own
- K142774: Polysmith Sleep System (2015), 4 descendants of its own
- K083456: Nihon Kohden CO2 Sensor Kit, Model TG-970P (2009), 3 descendants of its own

## Indications for use
The Nihon Kohden TG-901T CO₂ Sensor 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. The device is intended as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis. This device is intended for use with patients three (3) years of age and older. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less 22 pounds or patients with a respiration rate greater than or equal to 60 breaths per minute.

Source page: https://510kreport.com/device/K990063
Methodology: https://510kreport.com/methodology