Cleared Traditional

K963208 - NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)

K963208 is an FDA 510(k) clearance for NERVEPACE NERVE CONDUCTION VIEWSCOPE (2..., manufactured by Neurotron Medical. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K963208 · Neurotron Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
332d
Days
Class 2
Risk

K963208 is an FDA 510(k) clearance for the NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS). Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Neurotron Medical (Lawrenceville, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K963208

510(k) Number K963208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1996
Decision Date July 14, 1997
Days to Decision 332 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 149d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXE Device Classification - Class 2, Special Controls

Product Code JXE Device, Nerve Conduction Velocity Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXE Device, Nerve Conduction Velocity Measurement

All 22
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K963208.
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692 · Neurosoft, Inc. · Nov 2000
MODIFICATION TO NC-STAT
K000565 · Neurometrix, Inc. · Jun 2000
NC-STAT
K982359 · Neurometrix, Inc. · Oct 1998
INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
K935298 · Insta Nerve Canada, Inc. · Aug 1994
TD50 ELECTROMYOGRAPH
K935017 · Medelec Intl. Corp. · Jul 1994
SMARTSCOPE
K932533 · Insight Medical Corp. · Mar 1994
K963208 · NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
Download PDF Neurotron Medical