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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 / February 2026 / K251864

510(k) cleared

Rubber Utility Catheter

C.R. Bard, Inc. · Feb 23, 2026 · K251864

FDA cleared the Rubber Utility Catheter from C.R. Bard, Inc. on Feb 23, 2026 under K251864, a traditional 510(k). The device falls under product code KOD, Catheter, Urological, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 17, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

C.R. Bard, Inc. has 3 other decisions in the tracker over the last 12 months: K253514 (Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)), K254076 (BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit), K252971 (Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)).

Questions & Answers

What did FDA clear under K251864?

K251864 is the FDA 510(k) for Rubber Utility Catheter, submitted by C.R. Bard, Inc.. FDA's decision date was Feb 23, 2026, under product code KOD (Catheter, Urological).

Who makes the Rubber Utility Catheter?

C.R. Bard, Inc., based in Covington, GA, is the applicant of record for K251864.

How long did the K251864 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Feb 23, 2026, 251 days later.

← All decisions in February 2026