Cleared Traditional

K910624 - CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4

K910624 is an FDA 510(k) clearance for CASE IV COMPUTER AIDED SENSORY EVALUATO..., manufactured by Wr Medical Electronics Co.. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 339-day FDA review.

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.

FDA 510(k) Submission Details - K910624

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 149d · This submission: 339d
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.

Regulatory Peers - LLN Device, Vibration Threshold Measurement

All 12
Devices cleared under the same product code (LLN) and FDA review panel - the closest regulatory comparables to K910624.
VSA 3000 VIBRATORYN SENSORY ANALYZER
K970180 · Eare Consulting Service · Apr 1997
NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
K934368 · Nk Biotechnical Engineering Co. · Aug 1994
VIBROTACTILE TESTER, MODEL NO. VTT-100
K921560 · Topical Testing, Inc. · Oct 1992
TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
K872931 · Teca, Inc. · Nov 1987
VIBRATRON II, VIBRATION SENSITIVITY TESTER
K863607 · Sensortek, Inc. · Dec 1986
NEUROMETER
K853608 · Neurotron, Inc. · Jun 1986
K910624 · CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4
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