FDA cleared the BD Saf-T-Intima Subcutaneous Catheter System from Becton Dickinson Infusion Therapy Systems, Inc. on Oct 8, 2025 under K251422, a traditional 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on May 7, 2025. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Becton Dickinson Infusion Therapy Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K260128 (BD Preset and BD A-Line Arterial Blood Collection Syringes), K252378 (BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube), K252506 (BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder), K252137 (BD Insyte IV Catheter).