Cleared Traditional

CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (K910624) - FDA 510(k) Clearance

Class I Neurology device.

K910624 · Wr Medical Electronics Co. · Neurology device
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Jan 1992
Decision
339d
Days
Class 1
Risk

K910624 is an FDA 510(k) clearance for the CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Wr Medical Electronics Co. (Stillwater, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Wr Medical Electronics Co. devices

Submission Details

510(k) Number K910624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date January 17, 1992
Days to Decision 339 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 148d · This submission: 339d
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.