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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

This is the only decision on file for Changzhou Sifary Medical Technology Co., Ltd. in the last 12 months of the tracker.

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