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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 / K252224

510(k) cleared

Apex Locator (FindPex)

Changzhou Sifary Medical Technology Co., Ltd. · Apr 8, 2026 · K252224

FDA cleared the Apex Locator (FindPex) from Changzhou Sifary Medical Technology Co., Ltd. on Apr 8, 2026 under K252224, a traditional 510(k). The device falls under product code LQY, Locator, Root Apex as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 16, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Changzhou Sifary Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260795 (Hand-held Dental X-ray System (HyperLight-M)).

Questions & Answers

What did FDA clear under K252224?

K252224 is the FDA 510(k) for Apex Locator (FindPex), submitted by Changzhou Sifary Medical Technology Co., Ltd.. FDA's decision date was Apr 8, 2026, under product code LQY (Locator, Root Apex).

Who makes the Apex Locator (FindPex)?

Changzhou Sifary Medical Technology Co., Ltd., based in Changzhou, is the applicant of record for K252224.

How long did the K252224 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Apr 8, 2026, 266 days later.

← All decisions in April 2026

Sources