Cleared Traditional

K254183 - MR Conditional Cup Electrodes

K254183 is the FDA 510(k) clearance for MR Conditional Cup Electrodes by Technomed Europe. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K254183 · Technomed Europe · Neurology device
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May 2026
Decision
135d
Days
Class 2
Risk

K254183 is an FDA 510(k) clearance for the MR Conditional Cup Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Technomed Europe (Limburg, NL). The FDA issued a Cleared decision on May 7, 2026 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Technomed Europe devices

Submission Details

510(k) Number K254183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date May 07, 2026
Days to Decision 135 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
13d faster than avg
Panel avg: 148d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 141
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K254183.
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
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myosmart. (13E522)
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