Cleared Traditional

SPRY TMS Therapy System (0550)

K251653 · Soterix Medical, Inc. · Neurology
Feb 2026
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K251653 is an FDA 510(k) clearance for the SPRY TMS Therapy System (0550), a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Soterix Medical, Inc. (Woodbridge, US). The FDA issued a Cleared decision on February 20, 2026, 267 days after receiving the submission on May 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K251653 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date February 20, 2026
Days to Decision 267 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.