Technomed Europe · Class II · Cleared Mar 15, 2026
| K-number | K253581 |
| Device name | 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) |
| Applicant | Technomed Europe |
| Product code | IKT |
| Device class | Class II |
| Decision date | Mar 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.1385 |
The Disposable Concentric Needle Electrode (DCNE) is a single-use, sterile recording electrode inserted into muscle tissue to detect bioelectric signals for electromyography (EMG), electroencephalography (EEG), and nerve potential monitoring during clinical neurophysiological testing. It acts as an interface between the patient and EMG recording equipment, transmitting weak electrical signals from the body to the monitoring device.
The subject device differs from the predicate in joining method (crimping plus glue versus soldering), connector plating (tin versus gold), core wire material (stainless steel versus tungsten), tip geometry (15° trocar versus 12° trocar), and hub inner shape. Hub diameter, needle length, diameter, and sterility/sterilization remain identical to the predicate.
ISO 13485 quality management system requirements; ISO 10993-1 biological evaluation testing including cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity. Device labeling per 21 CFR 801 and UDI requirements per 21 CFR 801.20 and 830.300/830.320.
The subject device is substantially equivalent because it maintains the same intended use, principles of operation, and core functionality as the predicate (K990015). Although manufacturing modifications were made to the joining method, plating, core wire material, and tip geometry, non-clinical testing (visual inspection, puncture, impedance, tensile strength, biocompatibility) demonstrated these changes do not raise new or different safety or effectiveness questions. The same crimping system and new materials are supported by reference devices (K062437, K130136) previously cleared by the FDA.
View the full FDA submission: accessdata.fda.gov