510(k) K252137

BD Insyte™ IV Catheter by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code FOZ

K252137 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD Insyte™ IV Catheter". The FDA issued a decision of Substantially Equivalent on April 2, 2026. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.