Electrolyle Carbon Dioxide Electrodes
by Fisher Scientific Co., LLC 510(k)
Active
510(k) K831025
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831025 | Date16 Jun 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The device is an Electrode Measurement for Blood-Gases (Pco2, Po2) and Blood pH, specifically designed to measure carbon dioxide levels in clinical chemistry applications. These electrodes function as ion-selective sensors, enabling precise electrochemical detection of dissolved carbon dioxide in aqueous samples, such as blood or other physiological fluids. They are categorized under the Clinical Chemistry advisory committee and fall within Device Class II regulatory classification, adhering to strict performance standards for accuracy and reliability in laboratory settings.
Electrolyte Carbon Dioxide Electrodes are supplied as reusable, non-sterile instruments intended for use in clinical chemistry laboratories. They are regulated under 21 CFR 862.1120 and were granted FDA 510(k) clearance (K831025) in 1983, with a Substantially Equivalent determination by the Clinical Chemistry (CH) advisory panel. These electrodes require proper calibration and maintenance as per manufacturer guidelines to ensure accurate measurements. No MRI safety or sterility requirements are specified in the regulatory data.
Other devices from Fisher Scientific Co., LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Fisher Scientific Carbon Dioxide Electrode used for?
This device is designed as an ion-selective sensor for measuring dissolved carbon dioxide (CO₂) levels in aqueous samples, such as blood or other physiological fluids. It is specifically intended for clinical chemistry applications where accurate CO₂ measurement is critical, such as in laboratory settings for blood-gas analysis.
Are these electrodes reusable or single-use?
The Fisher Scientific Carbon Dioxide Electrodes are supplied as reusable instruments. They are not intended for single-use and require proper calibration and maintenance to ensure reliable performance over repeated use.
Do these electrodes come sterile?
No, these electrodes are explicitly labeled as non-sterile. They are intended for use in clinical chemistry laboratories, where sterility is not a requirement for the device itself, though proper handling and maintenance practices should still be followed.
What regulatory approvals apply to this device?
The device holds FDA 510(k) clearance (K831025) under the Clinical Chemistry advisory committee (CH) and is classified as a Device Class II product. It adheres to regulatory standards outlined in 21 CFR 862.1120, ensuring compliance with performance and safety requirements for clinical chemistry applications.
How should these electrodes be stored?
While specific storage instructions are not detailed in the regulatory data, reusable electrodes like these typically require proper storage to maintain functionality. This includes keeping them clean, dry, and protected from physical damage or contamination. Follow the manufacturer’s guidelines for calibration and maintenance to ensure accurate measurements and longevity.