JXE · Class II · 21 CFR 882.1550

FDA Product Code JXE: Device, Nerve Conduction Velocity Measurement

Leading manufacturers include Mde Orvosbiol?giai Kutat?, Fejleszto,.

27
Total
27
Cleared
157d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 427d recently vs 146d historically

FDA 510(k) Cleared Device, Nerve Conduction Velocity Measurement Devices (Product Code JXE)

27 devices
1–24 of 27
Cleared Mar 26, 2025
NM-01/CPT neurometer (NM-01/CPT)
K240189
Mde Orvosbiol?giai Kutat?, Fejleszto,
Neurology · 427d

About Product Code JXE - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code JXE since 1976, with 27 receiving FDA clearance (average review time: 157 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 JXE have taken an average of 427 days to reach a decision - up from 146 days historically. Manufacturers should account for longer review timelines in current project planning.

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