Cleared Traditional

K843486 - VIBRAMETER

K843486 is an FDA 510(k) clearance for VIBRAMETER, manufactured by Somedic AB. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K843486 · Somedic AB · Neurology device
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Dec 1984
Decision
109d
Days
Class 1
Risk

K843486 is an FDA 510(k) clearance for the VIBRAMETER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Somedic AB (Sweden, US). The FDA issued a Cleared decision on December 24, 1984 after a review of 109 days - within the typical 510(k) review window.

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 Somedic AB devices

FDA 510(k) Submission Details - K843486

510(k) Number K843486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date December 24, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 148d · This submission: 109d
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.