510(k) K250907

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set by Sol-Millennium Medical, Inc. — Product Code JKA

K250907 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set". The FDA issued a decision of Substantially Equivalent on April 30, 2025. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.