FDA cleared 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) from Technomed Europe on Mar 15, 2026 under K253581, a traditional 510(k). The device falls under product code IKT, Electrode, Needle, Diagnostic Electromyograph, regulated at 21 CFR 890.1385 as a Class 2 device. The review panel was Physical Medicine.
FDA logged the submission as received on Nov 17, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Technomed Europe has one other decision in the tracker over the last 12 months: K254183 (MR Conditional Cup Electrodes).
Questions & Answers
What did FDA clear under K253581?
K253581 is the FDA 510(k) for 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), submitted by Technomed Europe. FDA's decision date was Mar 15, 2026, under product code IKT (Electrode, Needle, Diagnostic Electromyograph).
Who makes 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)?
Technomed Europe, based in Kerkrade, is the applicant of record for K253581.
How long did the K253581 review take?
FDA received the submission on Nov 17, 2025 and issued its decision on Mar 15, 2026, 118 days later.