Cleared Traditional

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

Also marketed or referenced as:
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.

View all Technomed Europe devices

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.