Satellite K+ Blood Potassium Monitoring System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K897110 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the SATELLITE K+ Blood Potassium Monitoring System used for?

  The SATELLITE K+ Blood Potassium Monitoring System is designed to measure potassium levels in serum, plasma, and urine. These measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

• How is the SATELLITE K+ Blood Potassium Monitoring System supplied?

  The system is manufactured by Medisense, Inc. and is designed for clinical chemistry applications in healthcare settings. It allows for monitoring electrolyte balance without requiring blood draws for repeated measurements, making it convenient for continuous patient monitoring.

• What regulatory approvals does the SATELLITE K+ Blood Potassium Monitoring System have?

  The SATELLITE K+ Blood Potassium Monitoring System has received FDA 510(k) clearance as substantially equivalent under product code CEM. This clearance indicates that the device is substantially equivalent to legally marketed devices in the United States.

• In what healthcare settings is the SATELLITE K+ Blood Potassium Monitoring System typically used?

  The system is designed for clinical chemistry applications and is used in healthcare settings where monitoring electrolyte balance is important. It is particularly useful for situations where repeated blood draws are not desirable, allowing for continuous monitoring of potassium levels in serum, plasma, and urine.