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Ionometer EH-HK and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901041

by Fresenius Usa, Inc.

Identifiers

510(k) Number
K901041 FDA 510(k)
FDA Product Code
CEM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1600 FDA 510(k)
Regulation Number
862.1600 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ionometer EH-HK and Accessories is an Electrode, Ion Specific, Potassium, designed for measuring potassium ion concentrations in clinical chemistry applications. It functions as a precision analytical tool to assess electrolyte levels, supporting diagnostic and monitoring processes in laboratory settings.

This device is supplied as a reusable system with associated electrodes and accessories, intended for use in clinical chemistry laboratories. It requires proper calibration and maintenance per manufacturer instructions, with no specified sterility or single-use designation. The device is classified under FDA regulation 862.1600 and holds a Traditional 510(k) clearance (K901041) as Substantially Equivalent, with advisory committee classification under Clinical Chemistry. No MRI safety or size-specific storage requirements are noted in the regulatory data.

Frequently asked questions

What is the primary clinical use of the Ionometer EH-HK and Accessories in a laboratory setting?

The Ionometer EH-HK is designed specifically for measuring potassium ion concentrations in clinical chemistry applications. It serves as a precision analytical tool to assess electrolyte levels, which is critical for diagnostic and monitoring processes in laboratory settings, such as evaluating patient hydration status, renal function, or metabolic disorders.

Is the Ionometer EH-HK intended for single-use or reusable applications, and what maintenance is required?

The Ionometer EH-HK is supplied as a reusable system, meaning it is not single-use. It requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure accurate and reliable performance over time. No sterility designation is specified, so it is not intended for sterile procedures.

Are there specific storage requirements for the Ionometer EH-HK, such as temperature or environmental conditions?

The provided regulatory data does not specify any unique storage requirements like temperature or environmental conditions beyond standard laboratory practices. However, since it is reusable and requires calibration, it should be stored in a clean, dry environment to prevent contamination or damage to the electrodes and accessories.

How many different electrode models or variants are associated with this Ionometer system?

The Ionometer EH-HK system is linked to multiple electrode variants, as indicated by the extensive list of FEI numbers (e.g., 3006198300, 3000126629, etc.) in the regulatory data. These identifiers correspond to different electrode models or configurations designed for compatibility with the ionometer, ensuring flexibility for various clinical chemistry applications.

What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

The Ionometer EH-HK received a Traditional 510(k) clearance (K901041) under FDA regulation 862.1600, classified as *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for measuring potassium ion concentrations in clinical chemistry. The advisory committee classification under *Clinical Chemistry* confirms its specialized role in electrolyte analysis.

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: IONOMETER EH-HK AND ACCESSORIES (K901041) — FDA 510 (k) | Innolitics, Ionometer Eh-hk And Accessories 510 (k) FDA Premarket Notification ..., PDF K901041 - Ionometer Eh-hk and Accessories, api.fda.gov, Fresenius USA, Inc. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fresenius Usa, Inc.

Sources (1)

  • FDA 510(k) K901041 24 fields · synced Sep 19, 2026