Cleared Traditional

K251243 - OneRF Trigeminal Nerve Radiofrequency P...

K251243 is an FDA 510(k) clearance for OneRF Trigeminal Nerve Radiofrequency P..., manufactured by Neuroone Medical Technologies Corp.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K251243 · Neuroone Medical Technologies Corp. · Neurology device
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Aug 2025
Decision
115d
Days
Class 2
Risk

K251243 is an FDA 510(k) clearance for the OneRF Trigeminal Nerve Radiofrequency Probes. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on August 15, 2025 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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 Neuroone Medical Technologies Corp. devices

FDA 510(k) Submission Details - K251243

510(k) Number K251243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2025
Decision Date August 15, 2025
Days to Decision 115 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
33d faster than avg
Panel avg: 148d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 - GXI Probe, Radiofrequency Lesion

All 37
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K251243.
Disposable Radiofrequency Cannula
K253907 · Abbott Medical · Apr 2026
STAR RF Ablation System
K251802 · Merit Medical Systems, Inc. · Feb 2026
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · Abbott Medical · May 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · Stryker Instruments · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025
Intracept Intraosseous Nerve Ablation System
K222281 · Relievant Medsystems, Inc. · Oct 2022