510(k) K251636

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) by Baxter Healthcare Corporation — Product Code FRN

K251636 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)". The FDA issued a decision of Substantially Equivalent on July 28, 2025. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.