Cleared Traditional

K261228 - QuickVision Ultimate rTMS

K261228 is an FDA 510(k) clearance for QuickVision Ultimate rTMS, manufactured by Brain Ultimate, Inc.. The device is a Class 2 Neurology device with product code OBP cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K261228 · Brain Ultimate, Inc. · Neurology device
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Aug 2026
Decision
121d
Days
Class 2
Risk

K261228 is an FDA 510(k) clearance for the QuickVision Ultimate rTMS. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Brain Ultimate, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 14, 2026 after a review of 121 days - within the typical 510(k) review window.

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 Brain Ultimate, Inc. devices

FDA 510(k) Submission Details - K261228

510(k) Number K261228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2026
Decision Date August 14, 2026
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
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

Makromed, Inc.
Barry Ashar

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 66
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K261228.
BTL-699
K260691 · BTL Industries, Inc. · Aug 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189 · Tonica Elektronik A/S · May 2026
Apollo TMS Therapy System
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Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
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Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · Nexstim Oyj · Mar 2026
SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026