510(k) K252184

SOL-M Luer Lock Syringe with Exchangeable Needle Tray by Sol-Millennium Medical, Inc. — Product Code FMF

K252184 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "SOL-M Luer Lock Syringe with Exchangeable Needle Tray". The FDA issued a decision of Substantially Equivalent on August 25, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.