Cleared Traditional

K250689 - CloudTMS Edge (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250689 · Teleemg, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
192d
Days
Class 2
Risk

K250689 is an FDA 510(k) clearance for the CloudTMS Edge. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Teleemg, LLC (Los Angeles, US). The FDA issued a Cleared decision on September 14, 2025 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleemg, LLC devices

Submission Details

510(k) Number K250689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2025
Decision Date September 14, 2025
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Makromed, Inc.
Ashar Barry

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBP Transcranial Magnetic Stimulator

All 63
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K250689.
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · Nexstim Oyj · Mar 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · Nexstim Oyj · Mar 2026
SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026
BrainsWay Deep TMS System
K251391 · Brainsway , Ltd. · Nov 2025
BrainsWay Deep TMS System
K251449 · Brainsway , Ltd. · Sep 2025
Apollo TMS Therapy System
K243700 · Mag & More GmbH · Sep 2025