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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 / July 2026 / K253514

510(k) cleared

Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)

C.R. Bard, Inc. · Jul 10, 2026 · K253514

FDA cleared the Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) from C.R. Bard, Inc. on Jul 10, 2026 under K253514, a traditional 510(k). The device falls under product code KNT, Tubes, Gastrointestinal (And Accessories), regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 6, 2025. The decision came 246 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: 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)), K251864 (Rubber Utility Catheter).

Questions & Answers

What did FDA clear under K253514?

K253514 is the FDA 510(k) for Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300), submitted by C.R. Bard, Inc.. FDA's decision date was Jul 10, 2026, under product code KNT (Tubes, Gastrointestinal (And Accessories)).

Who makes the Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)?

C.R. Bard, Inc., based in Covington, GA, is the applicant of record for K253514.

How long did the K253514 review take?

FDA received the submission on Nov 6, 2025 and issued its decision on Jul 10, 2026, 246 days later.

← All decisions in July 2026

Sources