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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 / K252891

510(k) cleared

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

Bayer Medical Care, Inc. · Feb 13, 2026 · K252891

FDA cleared the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) from Bayer Medical Care, Inc. on Feb 13, 2026 under K252891, a traditional 510(k). The device falls under product code DXT, Injector And Syringe, Angiographic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 11, 2025. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bayer Medical Care, Inc. has one other decision in the tracker over the last 12 months: K253688 (MEDRAD® Imaging Bulk Package Transfer Spike).

Questions & Answers

What did FDA clear under K252891?

K252891 is the FDA 510(k) for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2), submitted by Bayer Medical Care, Inc.. FDA's decision date was Feb 13, 2026, under product code DXT (Injector And Syringe, Angiographic).

Who makes the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)?

Bayer Medical Care, Inc., based in Indianaola, PA, is the applicant of record for K252891.

How long did the K252891 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Feb 13, 2026, 155 days later.

← All decisions in February 2026

Sources