Cleared Traditional

K982359 - NC-STAT

K982359 is an FDA 510(k) clearance for NC-STAT, manufactured by Neurometrix, Inc.. The device is a Class 2 Neurology device with product code JXE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982359 · Neurometrix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
88d
Days
Class 2
Risk

K982359 is an FDA 510(k) clearance for the NC-STAT. Classified as Device, Nerve Conduction Velocity Measurement (product code JXE), Class II - Special Controls.

Submitted by Neurometrix, Inc. (North Attleboro, US). The FDA issued a Cleared decision on October 2, 1998 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K982359

510(k) Number K982359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date October 02, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 149d · This submission: 88d
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 19
Devices cleared under the same product code (JXE) and FDA review panel - the closest regulatory comparables to K982359.
NC-STAT
K003508 · Neurometrix, Inc. · Jan 2001
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692 · Neurosoft, Inc. · Nov 2000
MODIFICATION TO NC-STAT
K000565 · Neurometrix, Inc. · Jun 2000
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · Neurotron Medical · Jul 1997
INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
K935298 · Insta Nerve Canada, Inc. · Aug 1994
TD50 ELECTROMYOGRAPH
K935017 · Medelec Intl. Corp. · Jul 1994