510(k) K251640

SIGMA Spectrum Infusion Pump with Master Drug Library by Baxter Healthcare Corporation — Product Code FRN

K251640 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "SIGMA Spectrum Infusion Pump with Master Drug Library". 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.