Cleared Traditional

K901809 - LUMISCOPE ELECTRODES MODELS EL-08

K901809 is the FDA 510(k) clearance for LUMISCOPE ELECTRODES MODELS EL-08 by Lumiscope Co., Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K901809 · Lumiscope Co., Inc. · Neurology device
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Jun 1990
Decision
59d
Days
Class 2
Risk

K901809 is an FDA 510(k) clearance for the LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

View all Lumiscope Co., Inc. devices

Submission Details

510(k) Number K901809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date June 18, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 106
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