Cleared Traditional

K880573 - MODIFIED NICOLET VIKING SYSTEM

K880573 is an FDA 510(k) clearance for MODIFIED NICOLET VIKING SYSTEM, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K880573 · Nicolet Biomedical Instruments · Neurology device
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Mar 1988
Decision
41d
Days
Class 2
Risk

K880573 is an FDA 510(k) clearance for the MODIFIED NICOLET VIKING SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 41 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 - K880573

510(k) Number K880573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1988
Decision Date March 22, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 149d · This submission: 41d
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 K880573.
NICOLET VIKING II SYSTEM
K890495 · Nicolet Instrument Corp. · Mar 1989
AL-200B MUSCLE ACTIVITY INTEGRATOR
K880976 · Aaron Laboratories, Inc. · Apr 1988
ADR-2000 AMBULATORY DATA RECORDING SYSTEM
K880977 · Aaron Laboratories, Inc. · Apr 1988
SPINOSCOPE
K872836 · Diagnospine Fabrication, Inc. · Sep 1987
MODEL M402 EMG MONITOR
K864660 · Bio-Logic Devices · Feb 1987
EMG-1, MOTOR NERVE MONITOR
K864408 · Algotek, Inc. · Jan 1987
K880573 · MODIFIED NICOLET VIKING SYSTEM
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