Diagnostics PO2 Electrode Cleaner

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831010 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Diagnostics PO₂ Electrode Cleaner in a clinical lab setting?

  The Diagnostics PO₂ Electrode Cleaner is specifically designed to clean and maintain PO₂ electrodes used in clinical chemistry. Its purpose is to ensure accurate and reliable measurements of oxygen partial pressure (PO₂) in blood samples by removing contaminants after each use, thereby extending electrode lifespan and maintaining measurement precision.

• Is this device intended for single-use or repeated use, and how does that affect its sterility?

  This device is intended for single-use only in laboratory settings. It is supplied sterile, meaning it is pre-sterilized by the manufacturer to prevent contamination before first use. Since it is not designed for reuse, there is no need for additional sterilization steps after cleaning electrodes.

• How is the regulatory status of this device determined, and what does that mean for buyers?

  The Diagnostics PO₂ Electrode Cleaner is classified as a Class II medical device under FDA regulation 862.1120, with a 510(k) clearance (K831010). This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for its intended use in cleaning PO₂ electrodes. Buyers can rely on this clearance as confirmation of its compliance with FDA requirements.

• What type of electrodes is this cleaner compatible with, and where would it be used?

  This cleaner is specifically designed for PO₂ electrodes, which are used in clinical chemistry analyzers to measure oxygen partial pressure in blood samples. It is intended for use in laboratory settings, particularly where blood-gas analysis is performed, such as hospital labs, clinical chemistry departments, or research facilities.