Cleared Traditional

K890495 - NICOLET VIKING II SYSTEM

K890495 is an FDA 510(k) clearance for NICOLET VIKING II SYSTEM, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K890495 · Nicolet Instrument Corp. · Neurology device
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Mar 1989
Decision
43d
Days
Class 2
Risk

K890495 is an FDA 510(k) clearance for the NICOLET VIKING II SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 43 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.

View all Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K890495

510(k) Number K890495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date March 16, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
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 17
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K890495.
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
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K893130 · Bio-Logic Systems Corp. · Mar 1990
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · Del Mar Avionics · Oct 1982