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Multigas Unit Model AG-920RA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020046

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K020046 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Multigas Unit Model AG-920RA is a medical gas analyzer designed for monitoring anesthesia gases in clinical settings. It measures oxygen (O₂), nitrous oxide (N₂O), carbon dioxide (CO₂), and up to two anesthetic agents, including halothane, isoflurane, enflurane, sevoflurane, and desflurane, as well as respiration rate. This device supports precise gas concentration monitoring to ensure patient safety during anesthesia procedures.

The AG-920RA is intended for use in operating rooms and anesthesia care areas, where it is connected to patient monitoring systems to provide real-time gas analysis. Supplied as a reusable device, it requires proper maintenance and calibration to ensure accurate readings. The unit adheres to FDA 510(k) clearance under the product code CCK, with regulatory oversight by the Anesthesiology Advisory Committee. Storage and handling follow manufacturer guidelines to maintain performance and reliability.

Frequently asked questions

What clinical applications does the AG-920RA Multigas Unit support?

The AG-920RA is designed specifically for monitoring anesthesia gases in operating rooms and anesthesia care areas. It provides real-time analysis of oxygen (O₂), nitrous oxide (N₂O), carbon dioxide (CO₂), and up to two anesthetic agents, such as halothane, isoflurane, enflurane, sevoflurane, or desflurane. This ensures precise gas concentration monitoring to enhance patient safety during anesthesia procedures.

Is the AG-920RA a single-use or reusable device?

The AG-920RA is a reusable medical gas analyzer. Like all reusable devices, it requires regular maintenance, calibration, and adherence to manufacturer guidelines to ensure accurate and reliable performance over time.

What gases does the AG-920RA measure, and how does it contribute to patient safety?

The AG-920RA measures oxygen (O₂), nitrous oxide (N₂O), carbon dioxide (CO₂), and up to two anesthetic agents. By continuously analyzing these gases in real-time, it helps clinicians maintain optimal gas concentrations, reducing the risk of hypoxia, hypercarbia, or anesthetic overdose—critical factors in ensuring patient safety during anesthesia.

How should the AG-920RA be stored and handled?

Proper storage and handling are essential to maintain the performance and reliability of the AG-920RA. The manufacturer provides specific guidelines for storage conditions, including protection from extreme temperatures, humidity, and physical damage. Regular cleaning and calibration, as outlined in the user manual, are also required to ensure accurate gas readings.

What regulatory pathway does the AG-920RA follow, and who oversees its compliance?

The AG-920RA received FDA 510(k) clearance under product code CCK, with regulatory oversight by the Anesthesiology Advisory Committee. The device is classified as substantially equivalent to a predicate product, ensuring it meets established safety and performance standards for medical gas analyzers used in anesthesia.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AG-920RA/RK Multigas Unit Manual | PDF - Scribd, Nihon Kohden - AG-920RA Manuals and Documents | Medical - MedWrench, Nihon Kohden - AG-920RA Community, Manuals and Specifications | MedWrench, For Sale NIHON KOHDEN MULTIGAS UNIT Anesthesia Monitor

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K020046 24 fields · synced Oct 1, 2026