Cleared Traditional

K820414 - UNIVERSAL TESTING & ANALYSIS SYSTEMS

K820414 is an FDA 510(k) clearance for UNIVERSAL TESTING & ANALYSIS SYSTEMS, manufactured by Lkc Technologies, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820414 · Lkc Technologies, Inc. · Neurology device
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Mar 1982
Decision
20d
Days
Class 2
Risk

K820414 is an FDA 510(k) clearance for the UNIVERSAL TESTING & ANALYSIS SYSTEMS. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Lkc Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K820414

510(k) Number K820414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1982
Decision Date March 04, 1982
Days to Decision 20 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
129d faster than avg
Panel avg: 149d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 140
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K820414.
CADWELL 7400
K822214 · Cadwell Laboratories, Inc. · Sep 1982
THE 3500
K822396 · Tracor Northern, Inc. · Sep 1982
TECA MODEL SENSOR ER 94
K820908 · Teca, Inc. · May 1982
MODEL SIX BEAM SYSTEM
K811848 · Braintech, Inc. · Sep 1981
SOMATOSENSORY STIMULATOR
K810482 · Amplaid USA, Inc. · Apr 1981
TN-3000 EVOKED RESPONSE SYSTEM
K810560 · Tracor Northern, Inc. · Mar 1981
K820414 · UNIVERSAL TESTING & ANALYSIS SYSTEMS
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