JXE · Class II · 21 CFR 882.1550

FDA Product Code JXE: Device, Nerve Conduction Velocity Measurement

Leading manufacturers include Neurometrix, Inc., Chalgren Enterprises, Inc. and Neurosoft, Inc..

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
Cleared Sep 25, 2019
Mediracer NCS
K190536
Mediracer OY
Neurology · 205d
Cleared Apr 25, 2008
NEUROMETRIX ADVANCE
K070109
Neurometrix, Inc.
Neurology · 470d
Cleared Jul 31, 2006
NC-STAT
K060584
Neurometrix, Inc.
Neurology · 146d
Cleared Feb 07, 2006
XLTEK NEUROPATH, MODEL PK1070
K053058
Excel Tech. , Ltd.
Neurology · 99d
Cleared Oct 27, 2005
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
K052904
Scientific Imaging, Inc.
Neurology · 13d
Cleared Aug 12, 2004
MODIFICATION TO NC-STAT
K041320
Neurometrix, Inc.
Neurology · 86d
Cleared Jan 17, 2002
MODIFICATION OF NC-STAT
K013459
Neurometrix, Inc.
Neurology · 91d
Cleared Aug 01, 2001
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
K012069
Neurotron Medical, Inc.
Neurology · 30d
Cleared Jan 17, 2001
NC-STAT
K003508
Neurometrix, Inc.
Neurology · 64d
Cleared Nov 24, 2000
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692
Neurosoft, Inc.
Neurology · 175d
Cleared Jun 27, 2000
MODIFICATION TO NC-STAT
K000565
Neurometrix, Inc.
Neurology · 126d
Cleared Oct 02, 1998
NC-STAT
K982359
Neurometrix, Inc.
Neurology · 88d
Cleared Jul 14, 1997
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208
Neurotron Medical
Neurology · 332d
Cleared Oct 05, 1992
REUSABLE DUAL DISC BAR RECORDING ELECTRODES
K923665
Chalgren Enterprises, Inc.
Neurology · 75d
Cleared Sep 11, 1992
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504
Chalgren Enterprises, Inc.
Neurology · 164d
Cleared Feb 04, 1982
CADWELL 5200
K820031
Cadwell Laboratories, Inc.
Neurology · 29d

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 510(k) Review Time - JXE Product Code

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 →