Cleared Traditional

BraiN20® (BraiN20) (K253301) - FDA 510(k) Clearance

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

K253301 · Time IS Brain, S.L. · Neurology device
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Jun 2026
Decision
271d
Days
Class 2
Risk

K253301 is an FDA 510(k) clearance for the BraiN20® (BraiN20). Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Time IS Brain, S.L. (Badalona, ES). The FDA issued a Cleared decision on June 27, 2026 after a review of 271 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Time IS Brain, S.L. devices

Submission Details

510(k) Number K253301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 27, 2026
Days to Decision 271 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 148d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 Peers - GWF Stimulator, Electrical, Evoked Response

All 21
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K253301.
SafeOp 3: Neural Informatix System
K252842 · Alphatec Spine, Inc. · Jan 2026
Nicolet EDX
K243982 · Natus Neurology Incorporated · Jan 2025
Natus Ultrapro S100 (982A0594)
K243495 · Natus Neurology Incorporated · Dec 2024
Delphi Stimulator
K242345 · Quantalx Neuroscience · Nov 2024
SafeOp 3: Neural Informatix Systeem
K234092 · Alphatec Spine, Inc. · Apr 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc. · Mar 2024