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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 / April 2026 / K253975

510(k) cleared

Radical 6F Access Catheter

Maduro Medical, Inc. · Apr 9, 2026 · K253975

FDA cleared the Radical 6F Access Catheter from Maduro Medical, Inc. on Apr 9, 2026 under K253975, a special 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 11, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Maduro Medical, Inc. has one other decision in the tracker over the last 12 months: K261089 (Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit).

Questions & Answers

What did FDA clear under K253975?

K253975 is the FDA 510(k) for Radical 6F Access Catheter, submitted by Maduro Medical, Inc.. FDA's decision date was Apr 9, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Radical 6F Access Catheter?

Maduro Medical, Inc., based in Los Gatos, CA, is the applicant of record for K253975.

How long did the K253975 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Apr 9, 2026, 119 days later.

← All decisions in April 2026

Sources