Cleared Traditional

K253581 - Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) (FDA 510(k) Clearance)

Also includes:
Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002) Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006) Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003) Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004) Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

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

K253581 · Technomed Europe · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
118d
Days
Class 2
Risk

K253581 is an FDA 510(k) clearance for the Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001). Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Technomed Europe (Kerkrade, NL). The FDA issued a Cleared decision on March 15, 2026 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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.

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Submission Details

510(k) Number K253581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date March 15, 2026
Days to Decision 118 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
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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.