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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 / K253638

510(k) cleared

xStep (xStep)

Spinex, Inc. · Apr 20, 2026 · K253638

FDA cleared the xStep (xStep) from Spinex, Inc. on Apr 20, 2026 under K253638, a traditional 510(k). The device falls under product code SDO, Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation, regulated at 21 CFR 890.5851 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 19, 2025. The decision came 152 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 Spinex, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253638?

K253638 is the FDA 510(k) for xStep (xStep), submitted by Spinex, Inc.. FDA's decision date was Apr 20, 2026, under product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation).

Who makes the xStep (xStep)?

Spinex, Inc., based in Fremont, CA, is the applicant of record for K253638.

How long did the K253638 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Apr 20, 2026, 152 days later.

← All decisions in April 2026