Arterial Blood Gassing Monitoring System (ABG)

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

510(k) Number

K870016 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Is this device intended for continuous or intermittent monitoring of arterial blood gases, and where would it be primarily used in a clinical setting?

  The Arterial Blood Gassing Monitoring System (ABG) is designed for both continuous and intermittent monitoring of arterial blood gases, including PaO₂, CO₂, pH, and bicarbonate levels. It is specifically intended for use in critical care environments such as intensive care units (ICUs), operating rooms, and emergency departments, where real-time physiological assessment is essential for managing respiratory and metabolic function.

• How is the device supplied, and is it meant for single-use or reusable applications?

  The ABG system is supplied as a disposable monitoring solution, meaning each unit is intended for single-use only. This design ensures sterility and reliability in sterile clinical environments like hospital wards or critical care units, where maintaining hygiene is critical.

• What regulatory pathway was followed for FDA clearance, and what does this mean for its use in the U.S.?

  The device underwent a traditional review pathway under FDA 510(k) clearance (K870016), which means it was compared to a legally marketed predicate device to demonstrate substantial equivalence. This clearance confirms it meets FDA standards for safety and effectiveness as outlined in 21 CFR 870.3680, allowing it to be legally marketed and used in the U.S. for its intended purposes.

• Does the device require any special preparation or calibration before use, and why is this important?

  Yes, the ABG system requires calibration prior to use. This step is critical to ensure accurate and reliable measurement of arterial blood gases, as calibration compensates for potential variations in sensor performance or environmental conditions, guaranteeing clinically dependable results for patient assessment.

• What types of physiological parameters does this device measure, and why are these measurements important in clinical practice?

  The device measures partial pressures of oxygen (PaO₂) and carbon dioxide (CO₂), pH levels, and bicarbonate concentrations. These parameters are vital for evaluating a patient’s respiratory function (e.g., oxygenation and ventilation) and metabolic balance (e.g., acid-base status), enabling clinicians to make timely interventions in critical care settings.