Cleared Traditional

K000565 - MODIFICATION TO NC-STAT

K000565 is an FDA 510(k) clearance for MODIFICATION TO 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 126-day FDA review.

K000565 · Neurometrix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
126d
Days
Class 2
Risk

K000565 is an FDA 510(k) clearance for the MODIFICATION TO 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 June 27, 2000 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K000565

510(k) Number K000565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date June 27, 2000
Days to Decision 126 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
23d faster than avg
Panel avg: 149d · This submission: 126d
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 K000565.
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
K012069 · Neurotron Medical, Inc. · Aug 2001
NC-STAT
K003508 · Neurometrix, Inc. · Jan 2001
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692 · Neurosoft, Inc. · Nov 2000
NC-STAT
K982359 · Neurometrix, Inc. · Oct 1998
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
K963208 · Neurotron Medical · Jul 1997
INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
K935298 · Insta Nerve Canada, Inc. · Aug 1994