Cleared Traditional

Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); 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)

K253581 · Technomed Europe · Neurology

Mar 2026

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K253581 is an FDA 510(k) clearance for the Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); 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), a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Technomed Europe (Kerkrade, NL). The FDA issued a Cleared decision on March 15, 2026, 118 days after receiving the submission on November 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.

Submission Details

510(k) Number	K253581 FDA.gov
FDA Decision	Cleared 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