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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 / June 2026 / K253688

510(k) cleared

MEDRAD® Imaging Bulk Package Transfer Spike

Bayer Medical Care, Inc. · Jun 12, 2026 · K253688

FDA cleared the MEDRAD® Imaging Bulk Package Transfer Spike from Bayer Medical Care, Inc. on Jun 12, 2026 under K253688, a traditional 510(k). The device falls under product code PQH, Iodinated Contrast Media Transfer Tubing Set, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 21, 2025. The decision came 203 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: K262043 (MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); 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 K253688?

K253688 is the FDA 510(k) for MEDRAD® Imaging Bulk Package Transfer Spike, submitted by Bayer Medical Care, Inc.. FDA's decision date was Jun 12, 2026, under product code PQH (Iodinated Contrast Media Transfer Tubing Set).

Who makes the MEDRAD® Imaging Bulk Package Transfer Spike?

Bayer Medical Care, Inc., based in Indianaola, PA, is the applicant of record for K253688.

How long did the K253688 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jun 12, 2026, 203 days later.

← All decisions in June 2026

Sources