# K992455: Nihon Kohden Ogs-2001A Pocketcare and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jan 7, 2000 after 168 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K973918: Nihon Kohden BSM-1101 and BSM-1102 Patient Monitor and Accessories, Nihon Kohden America, Inc. (1998) Summary page 1.

## Indications for use
Nihon Kohden's model number OGS-2001A is intended for medical use to measure the blood oxygen saturation (SpO,) and to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status (CO,). This product will be available for use by medical personnel within a medical facility or in a remote environment including transport. This device is not intended to be the sole basis of diagnosis. The CO, function of the device is intended for patients three (3) years and above and is not recommended for patients with low tidal volume such as patients weighing less than 22 pounds or patients with a respiratory rate greater than 60 breaths per minute. The CO, function will be available for all other patient populations.

Source page: https://510kreport.com/device/K992455
Methodology: https://510kreport.com/methodology