WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K253235

510(k) cleared

Introcan Safety® Deep Access XL IV Catheter

B.Braun Medical, Inc. · May 15, 2026 · K253235

FDA cleared the Introcan Safety® Deep Access XL IV Catheter from B.Braun Medical, Inc. on May 15, 2026 under K253235, 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 Sep 29, 2025. The decision came 228 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for B.Braun Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253235?

K253235 is the FDA 510(k) for Introcan Safety® Deep Access XL IV Catheter, submitted by B.Braun Medical, Inc.. FDA's decision date was May 15, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the Introcan Safety® Deep Access XL IV Catheter?

B.Braun Medical, Inc., based in Bethlehem, PA, is the applicant of record for K253235.

How long did the K253235 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 15, 2026, 228 days later.

← All decisions in May 2026