Cleared Traditional

K991769 - CUTANEOUS (BAR) ELECTRODE

K991769 is an FDA 510(k) clearance for CUTANEOUS (BAR) ELECTRODE, manufactured by Neuro Supplies, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K991769 · Neuro Supplies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
86d
Days
Class 2
Risk

K991769 is an FDA 510(k) clearance for the CUTANEOUS (BAR) ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Neuro Supplies, Inc. (Waterford, US). The FDA issued a Cleared decision on August 18, 1999 after a review of 86 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 Neuro Supplies, Inc. devices

FDA 510(k) Submission Details - K991769

510(k) Number K991769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date August 18, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 266
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K991769.
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
ULTRA-GARMENT ELECTRODE
K993130 · Newwave Medical, LLC · Dec 1999
TENS/FES/NMES ELECTRODES
K983097 · Uni-Patch, Inc. · Sep 1999
CUTANEOUS (GROUND) ELECTRODE
K991770 · Neuro Supplies, Inc. · Aug 1999
DIGITAL RING ELECTRDE
K991771 · Neuro Supplies, Inc. · Aug 1999
CUTANEOUS (DISC) ELECTRODE
K991772 · Neuro Supplies, Inc. · Aug 1999