FDA 510(k)

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

K-Number: K251636 · 2025-07-28

Decision Date2025-07-28

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-07-28 under approval number K251636. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K251636.

When was Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) approved by the FDA?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) received FDA 510(k) clearance on 2025-07-28, under approval number K251636.

What company makes Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

The FDA product code for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is FRN.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.