BD Insyte IV Catheter (K252137): 510(k) cleared Apr 2, 2026

BD Insyte IV Catheter

Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2, 2026 · K252137

FDA cleared the BD Insyte IV Catheter from Becton Dickinson Infusion Therapy Systems, Inc. on Apr 2, 2026 under K252137, 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 Jul 8, 2025. The decision came 268 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), K260184 (Onclarity Self-Collection Kit).

Questions & Answers

What did FDA clear under K252137?

K252137 is the FDA 510(k) for BD Insyte IV Catheter, submitted by Becton Dickinson Infusion Therapy Systems, Inc.. FDA's decision date was Apr 2, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the BD Insyte IV Catheter?

Becton Dickinson Infusion Therapy Systems, Inc., based in Sandy, UT, is the applicant of record for K252137.

How long did the K252137 review take?

FDA received the submission on Jul 8, 2025 and issued its decision on Apr 2, 2026, 268 days later.

← All decisions in April 2026