Cleared Traditional

K251243 - OneRF Trigeminal Nerve Radiofrequency Probes (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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 65
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