IKT · Class II · 21 CFR 890.1385

FDA Product Code IKT: Electrode, Needle, Diagnostic Electromyograph

Leading manufacturers include Technomed Europe.

43
Total
43
Cleared
192d
Avg days
1986
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 118d recently vs 194d historically

FDA 510(k) Cleared Electrode, Needle, Diagnostic Electromyograph Devices (Product Code IKT)

43 devices
1–24 of 43
Cleared Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
K253581
Technomed Europe
Neurology · 118d

About Product Code IKT - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code IKT since 1986, with 43 receiving FDA clearance (average review time: 192 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under IKT have taken an average of 118 days to reach a decision - down from 194 days historically, suggesting improved FDA processing for this classification.

IKT devices are reviewed by the Neurology panel. Browse all Neurology devices →