510(k) K243392

Infusomat® Space Volumetric Infusion Pump Administration Sets by B.Braun Medical, Inc. — Product Code FPA

K243392 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Infusomat® Space Volumetric Infusion Pump Administration Sets". The FDA issued a decision of Substantially Equivalent on July 24, 2025. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.