510(k) K250700

Pen Injector Needle 32.5 by Terumo Corporation — Product Code FMI

K250700 is an FDA 510(k) premarket notification submitted by Terumo Corporation for the device "Pen Injector Needle 32.5". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Terumo Corporation has at least 10 other 510(k) clearances on record.