Spectrum IQ Infusion System with Dose IQ Safety Software

No FDA recalls found in the data synced 24 Oct 2026.

510(k) Number

K222048 ↗

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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See all devices from Baxter Healthcare Corporation →

• What types of fluids and medications can the Spectrum IQ Infusion System administer, and how does it ensure patient safety during infusion therapy?

  The Spectrum IQ Infusion System is designed for the controlled administration of fluids, pharmaceutical drugs, blood, and blood products, covering both intravenous and enteral applications. Its integrated Dose IQ Safety Software enhances patient safety by validating drug dosing and ensuring compliance with a centralized drug library, reducing risks associated with high-alert medications through dose verification and parameter checks.

• Is the Spectrum IQ Infusion System reusable, and what storage conditions are required to maintain its functionality?

  Yes, the Spectrum IQ Infusion System is supplied as a reusable medical device. To maintain its functionality, it must be stored in a clean, dry environment, as specified in the manufacturer’s guidelines. Proper storage ensures the device remains operational for repeated use in hospital settings.

• What types of pumps does the Spectrum IQ Infusion System support, and how does this flexibility benefit clinical workflows?

  The Spectrum IQ Infusion System supports both large-volume and syringe pumps, accommodating a wide range of clinical applications. This flexibility allows healthcare providers to use the system for diverse infusion needs, such as administering medications, fluids, or blood products, while maintaining centralized safety controls through its integrated software platform.

• Can the Spectrum IQ Infusion System be used in an MRI environment, and if not, what alternatives should clinicians consider?

  No, the Spectrum IQ Infusion System is explicitly stated as not MRI-compatible. Clinicians should avoid using it in MRI environments and instead rely on alternative infusion devices or protocols that are MRI-safe if the patient requires concurrent MRI imaging.

• How does the Spectrum IQ Infusion System’s regulatory pathway differ from other infusion pumps, and what does this mean for hospitals?

  The Spectrum IQ Infusion System holds FDA 510(k) clearance under the classification for infusion pumps (Device Class II) and is regulated under 21 CFR 880.5725. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for hospital use. Hospitals can rely on this regulatory clearance as part of their procurement and compliance processes.