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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 / K253926

510(k) cleared

Diacore

ShenB Co., Ltd. · Apr 10, 2026 · K253926

FDA cleared the Diacore from ShenB Co., Ltd. on Apr 10, 2026 under K253926, a traditional 510(k). The device falls under product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 8, 2025. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for ShenB Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253926?

K253926 is the FDA 510(k) for Diacore, submitted by ShenB Co., Ltd.. FDA's decision date was Apr 10, 2026, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the Diacore?

ShenB Co., Ltd., based in Seoul, is the applicant of record for K253926.

How long did the K253926 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Apr 10, 2026, 123 days later.

← All decisions in April 2026