Cleared Traditional

K883781 - NICOLET NEUROPORT/ACE SYSTEM

K883781 is an FDA 510(k) clearance for NICOLET NEUROPORT/ACE 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 272-day FDA review.

K883781 · Nicolet Instrument Corp. · Neurology device
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Jun 1989
Decision
272d
Days
Class 2
Risk

K883781 is an FDA 510(k) clearance for the NICOLET NEUROPORT/ACE 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 June 5, 1989 after a review of 272 days - an extended review 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: 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.

View all Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K883781

510(k) Number K883781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date June 05, 1989
Days to Decision 272 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 148d · This submission: 272d
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 K883781.
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp. · Jul 1993
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
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