# K040875: Cap-One, Model TG-920P

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Oct 15, 2004 after 196 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: 3 generations back to K915494 (1993). 3 ancestors in all.
13 later devices descend from it; 3 cite 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)
- K990063: Nihon Kohden TG-901T CO2 Sensor Kit with Accessories, Nihon Kohden America, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K173868: Serenity Body Position Sensor, Serenity RIP Sensors (2018), 1 descendant of its own

## Indications for use
The Nihon Kohden TG-920P 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/K040875
Methodology: https://510kreport.com/methodology