Cleared Traditional

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

K251636 · Baxter Healthcare Corporation · General Hospital
Jul 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K251636 is an FDA 510(k) clearance for the Spectrum IQ Infusion System with Dose IQ Safety Software (3570009), a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on July 28, 2025, 60 days after receiving the submission on May 29, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K251636 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date July 28, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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