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ABL510 Blood Gas System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K904513

by Radiometer America, Inc.

Identifiers

510(k) Number
K904513 FDA 510(k)
FDA Product Code
CHL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1120 FDA 510(k)
Regulation Number
862.1120 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ABL510 Blood Gas System is an electrode measurement device designed for blood-gas analysis, including partial pressure of carbon dioxide (Pco2), partial pressure of oxygen (Po2), and blood pH. It is intended for use in clinical settings to assess respiratory and metabolic conditions.

The device is supplied as a single-use system and is not reusable. It is not MRI safe. The ABL510 Blood Gas System is regulated under FDA 510(k) clearance (K904513) and is classified as a Class II medical device. Storage requirements are not specified in the provided data.

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: ABL510 BLOOD GAS SYSTEM (K904513) — FDA 510 (k) | Innolitics, K935655 - ABL5 BLOOD GAS SYSTEM | FDA 510 (k), PDF K904513 ABL510 BLOOD GAS SYSTEM - 510kdatabase.net, ABL510 BLOOD GAS SYSTEM 510 (k) K904513 - FDA.report, Acute care diagnostics solutions - Radiometer America

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radiometer America, Inc.

Sources (1)

  • FDA 510(k) K904513 24 fields · synced Sep 23, 2026