Cleared Traditional

K001562 - NEURO SCAN MEDICAL SYSTEMS A4000

K001562 is an FDA 510(k) clearance for NEURO SCAN MEDICAL SYSTEMS A4000, manufactured by Neuro Scan Labs. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K001562 · Neuro Scan Labs · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
89d
Days
Class 2
Risk

K001562 is an FDA 510(k) clearance for the NEURO SCAN MEDICAL SYSTEMS A4000. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Neuro Scan Labs (El Paso, US). The FDA issued a Cleared decision on August 16, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 - K001562

510(k) Number K001562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date August 16, 2000
Days to Decision 89 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
60d faster than avg
Panel avg: 149d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 74
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K001562.
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · Nihon Kohden America, Inc. · Jun 2001
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
K002104 · Maryrose Cusimano, Ph.D. & Scott Zeff · Oct 2000
ACCUWARM EMG HEAT LAMP
K001800 · Rjl Associates, LLC · Sep 2000
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
K000812 · Neurosoft, Inc. · May 2000
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · Motion Lab Systems, Inc. · Feb 2000
JE 2000
K993878 · Jack'S Electrodes · Feb 2000
K001562 · NEURO SCAN MEDICAL SYSTEMS A4000
Download PDF FDA Summary Neuro Scan Labs