510(k) K250724

Intraosseous Infusion Needles by Spectrum Vascular — Product Code FMI

K250724 is an FDA 510(k) premarket notification submitted by Spectrum Vascular for the device "Intraosseous Infusion Needles". The FDA issued a decision of Substantially Equivalent on July 30, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Spectrum Vascular has at least 4 other 510(k) clearances on record.