Cleared Traditional

K260396 - KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

K260396 is an FDA 510(k) clearance for KCS rTMS Therapy System (Transcranial M..., manufactured by Fidelity BioPharma Co.. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K260396 · Fidelity BioPharma Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
212d
Days
Class 2
Risk

K260396 is an FDA 510(k) clearance for the KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, Met.... Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Fidelity BioPharma Co. (New Haven, US). The FDA issued a Cleared decision on September 6, 2026 after a review of 212 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 Fidelity BioPharma Co. devices

FDA 510(k) Submission Details - K260396

510(k) Number K260396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2026
Decision Date September 06, 2026
Days to Decision 212 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
63d slower than avg
Panel avg: 149d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBP Device Classification - Class 2, Special Controls

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

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

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 68
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K260396.
BTL-699
K260691 · BTL Industries, Inc. · Aug 2026
QuickVision Ultimate rTMS
K261228 · Brain Ultimate, Inc. · Aug 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189 · Tonica Elektronik A/S · May 2026
Apollo TMS Therapy System
K260560 · Mag & More GmbH · May 2026
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