510(k) K243855

BD Alaris Infusion System with Guardrails Suite MX by Carefusion 303, Inc. — Product Code FRN

K243855 is an FDA 510(k) premarket notification submitted by Carefusion 303, Inc. for the device "BD Alaris Infusion System with Guardrails Suite MX". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Carefusion 303, Inc. has at least 6 other 510(k) clearances on record.