BD Saf-T-Intima? Subcutaneous Catheter System

About This 510(k) Submission

K251422 is an FDA 510(k) clearance for the BD Saf-T-Intima? Subcutaneous Catheter System, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on October 8, 2025, 154 days after receiving the submission on May 7, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.