# K020046: Multigas Unit, Model AG-920RA

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jul 25, 2002 after 199 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 K951127 (1995). 4 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954962: Spacelabs Medical Multigas Analyzer, Spacelabs, Inc. (1996) Summary page 1.
- K965062: Siemens SC9000/SC9015 Multigas and Multigas+ Modules, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K030105: Anesthesia Monitor; Bedside Monitor, Series BSM-5130A (2003), 14 descendants of its own
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series (2008), 11 descendants of its own
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series (2008), 5 descendants of its own
- K151080: Nihon Kohden CSM 1901 Bedside Monitor (2015), 4 descendants of its own
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), 3 descendants of its own

## Indications for use
The device currently marketed per KO01693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and is available for use by medical personnel on patients within a medical facility including adults, children and infants. The optional AG-920RA module will measure carbon dioxide (C02), nitrous oxide (N20), oxygen (02), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

Source page: https://510kreport.com/device/K020046
Methodology: https://510kreport.com/methodology