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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K262043

510(k) cleared

MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike

Bayer Medical Care, Inc. · Oct 6, 2026 · K262043

FDA cleared the MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike from Bayer Medical Care, Inc. on Oct 6, 2026 under K262043, 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 Jun 17, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bayer Medical Care, Inc. has 2 other decisions in the tracker over the last 12 months: K253688 (MEDRAD® Imaging Bulk Package Transfer Spike), K252891 (MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)).

Questions & Answers

What did FDA clear under K262043?

K262043 is the FDA 510(k) for MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike, submitted by Bayer Medical Care, Inc.. FDA's decision date was Oct 6, 2026, under product code DXT (Injector And Syringe, Angiographic).

Who makes the MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike?

Bayer Medical Care, Inc., based in Indianola, PA, is the applicant of record for K262043.

How long did the K262043 review take?

FDA received the submission on Jun 17, 2026 and issued its decision on Oct 6, 2026, 111 days later.

← All decisions in October 2026

Sources