Model 560 Series Volumetric Infusion Pump

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 560 Series Volumetric Infusion

510(k) Number

K811238 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What clinical environments is the Model 560 Series Volumetric Infusion Pump intended for use in, and why is this important for purchasing decisions?

  The Model 560 Series is explicitly authorized for use in general hospital environments, as indicated by its regulatory submissions and advisory committee designation. This specificity ensures compatibility with standard hospital protocols, making it a reliable choice for acute care settings where precise fluid administration is critical. Buyers should prioritize this device if their facility aligns with general hospital operations, as it avoids the need for specialized configurations.

• How is the Model 560 Series Volumetric Infusion Pump supplied, and does it require sterilization between uses?

  The Model 560 Series is a reusable device, meaning it is designed for repeated use within a clinical setting without requiring sterilization between patients. This simplifies inventory management and reduces operational costs, as it eliminates the need for single-use packaging or sterilization cycles. However, proper cleaning and maintenance per manufacturer guidelines remain essential to ensure safety and functionality.

• What types of configurations or models are available for the Model 560 Series, and how might this affect my purchase decision?

  The Model 560 Series includes multiple configurations, as evidenced by the extensive list of FEI numbers (e.g., 3009754410, 3008717264) under its regulatory submissions. These variations likely correspond to different flow rates, infusion volumes, or connectivity options. Buyers should verify the specific FEI numbers or consult the manufacturer to ensure the chosen model meets their facility’s requirements for dosing precision and workflow compatibility.

• Is the Model 560 Series Volumetric Infusion Pump suitable for use in MRI environments, and what should I consider if it isn’t?

  The device is not authorized for MRI environments, as explicitly stated in its description. If your facility requires MRI-compatible infusion pumps, this model would not be suitable. Alternatives should be evaluated to ensure patient safety, as MRI environments pose unique risks to electronic medical devices due to electromagnetic interference. Always confirm compatibility with your facility’s imaging protocols before purchasing.

• What regulatory pathway was followed for the Model 560 Series, and what does this mean for its compliance and approval status?

  The Model 560 Series received FDA 510(k) clearance (K811238) under a traditional review pathway, with a decision date of June 2, 1981. This clearance indicates the device was deemed substantially equivalent to a legally marketed predicate, adhering to 21 CFR 880.5725. While this confirms regulatory compliance for general hospital use, buyers should verify the specific predicate device and ensure the model aligns with current clinical standards, particularly if considering updates or modifications to the original design.