K253581 is an FDA 510(k) clearance for the Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001). This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.1385.
| 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 |
| Product Code | IKT — Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1385 |