# K964305: Nihon Kohden Olg-100A Pocketcap Pocket CO2 Monitor with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Feb 19, 1997 after 113 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: 1 generation back to K915494 (1993). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915494: Nellcor Stat-Cap Airway CO2 Indicator, Model N-60, Nellcor, Inc. (1993) Summary page 1.

## Most influential descendants
- K990063: Nihon Kohden TG-901T CO2 Sensor Kit with Accessories (1999), 14 descendants of its own
- 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

## Indications for use
The Nihon Kohden PocketCap Pocket CO, Monitor, model number OLG-1100A, 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. The device will be available for use only by medical personnel within a hospital or other medical facility, at a remote site, or during transport from a remote site to a hospital or other medical facility. 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/K964305
Methodology: https://510kreport.com/methodology