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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 / February 2026 / K251653

510(k) cleared

SPRY TMS Therapy System (0550)

Soterix Medical, Inc. · Feb 20, 2026 · K251653

FDA cleared the SPRY TMS Therapy System (0550) from Soterix Medical, Inc. on Feb 20, 2026 under K251653, a traditional 510(k). The device falls under product code OBP, Transcranial Magnetic Stimulator, regulated at 21 CFR 882.5805 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 29, 2025. The decision came 267 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 Soterix Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251653?

K251653 is the FDA 510(k) for SPRY TMS Therapy System (0550), submitted by Soterix Medical, Inc.. FDA's decision date was Feb 20, 2026, under product code OBP (Transcranial Magnetic Stimulator).

Who makes the SPRY TMS Therapy System (0550)?

Soterix Medical, Inc., based in Woodbridge, NJ, is the applicant of record for K251653.

How long did the K251653 review take?

FDA received the submission on May 29, 2025 and issued its decision on Feb 20, 2026, 267 days later.

← All decisions in February 2026