Cleared Traditional

K000812 - NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)

K000812 is an FDA 510(k) clearance for NEURO SCAN MEDICAL SYSTEMS, manufactured by Neurosoft, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K000812 · Neurosoft, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
65d
Days
Class 2
Risk

K000812 is an FDA 510(k) clearance for the NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTA.... Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Neurosoft, Inc. (El Paso, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 65 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 - K000812

510(k) Number K000812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date May 17, 2000
Days to Decision 65 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
84d faster than avg
Panel avg: 149d · This submission: 65d
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 K000812.
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 A4000
K001562 · Neuro Scan Labs · Aug 2000
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · Motion Lab Systems, Inc. · Feb 2000
JE 2000
K993878 · Jack'S Electrodes · Feb 2000
CERSR ELECTROMYOGRAPHY SYSTEM
K990766 · Paraspinal Diagnostic Corp. · Aug 1999
K000812 · NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
Download PDF FDA Summary Neurosoft, Inc.