510(k) K262532

NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) by ICU Medical — Product Code LGZ

K262532 is an FDA 510(k) premarket notification submitted by ICU Medical for the device "NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. ICU Medical has at least 10 other 510(k) clearances on record.