Cleared Traditional

K853804 - VICON (MODIFICATION)

K853804 is an FDA 510(k) clearance for VICON (MODIFICATION), manufactured by Oxford Metrics, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K853804 · Oxford Metrics, Inc. · Neurology device
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Dec 1985
Decision
107d
Days
Class 2
Risk

K853804 is an FDA 510(k) clearance for the VICON (MODIFICATION). Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Oxford Metrics, Inc. (Clearwater, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 107 days - within the typical 510(k) review window.

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 Oxford Metrics, Inc. devices

FDA 510(k) Submission Details - K853804

510(k) Number K853804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1985
Decision Date December 27, 1985
Days to Decision 107 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
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 43
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K853804.
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
MODIFIED NICOLET VIKING SYSTEM
K880573 · Nicolet Biomedical Instruments · Mar 1988
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
NICOLET VIKING
K842956 · Nicolet Biomedical Instruments · Aug 1984
CA2000
K842611 · Nicolet Biomedical Instruments · Jul 1984
COMPACT AUDITORY
K842612 · Nicolet Biomedical Instruments · Jul 1984