Cleared Traditional

K853608 - NEUROMETER

K853608 is an FDA 510(k) clearance for NEUROMETER, manufactured by Neurotron, Inc.. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K853608 · Neurotron, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K853608

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.

LLN Device Classification - Class 1, General Controls

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.