Cleared Traditional

NEUROMETER (K853608) - FDA 510(k) Clearance

Class I Neurology device.

K853608 · Neurotron, Inc. · Neurology device
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Jun 1986
Decision
288d
Days
Class 1
Risk

K853608 is an FDA 510(k) clearance for the NEUROMETER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Neurotron, Inc. (Baltimore, US). The FDA issued a Cleared decision on June 12, 1986 after a review of 288 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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 Neurotron, Inc. devices

Submission Details

510(k) Number K853608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1985
Decision Date June 12, 1986
Days to Decision 288 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 148d · This submission: 288d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.