# K062115: Carbon Dioxide Monitor, Model Olg-2800A

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Dec 27, 2006 after 156 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 K951127 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030105: Anesthesia Monitor; Bedside Monitor, Series BSM-5130A, Nihon Kohden America, Inc. (2003) Summary page 1.

## Most influential descendants
- K171765: Nihon Kohden CO2 Monitor (2017), 0 descendants of its own

## Indications for use
The OLG-2800A is a portable monitor that measures respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and non-intubated patients. The device displays waveforms and numeric data of monitored parameters, such as: CO 2, EtCO 2, respiratory rate, and trendgraphs. The device may generate an audible and/or visual alarm when a measured parameter falls outside preset limits. The device LED display shows ETCO 2 value and respiration rate and the LCD display shows CO 2 waveforms, and alarm settings. The device is AC and/or battery operated. This device will be available for use by medical personnel on all patient populations depending on the CO 2 sensor kit.

Source page: https://510kreport.com/device/K062115
Methodology: https://510kreport.com/methodology