Cleared Abbreviated

K003896 - LYMPHA VISION-EXPERT

K003896 is an FDA 510(k) clearance for LYMPHA VISION-EXPERT, manufactured by Bexley Trading, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 492-day FDA review.

K003896 · Bexley Trading, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
492d
Days
Class 2
Risk

K003896 is an FDA 510(k) clearance for the LYMPHA VISION-EXPERT. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bexley Trading, Inc. (Folsom, US). The FDA issued a Cleared decision on April 24, 2002 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K003896

510(k) Number K003896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2000
Decision Date April 24, 2002
Days to Decision 492 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 149d · This submission: 492d
Pathway characteristics
Standards-based clearance path.

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 439
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K003896.
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
K022197 · The Electrode Store, Inc. · Aug 2002
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020735 · Cathay International, Ltd. · Jul 2002
THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
K020445 · The Electrode Store, Inc. · May 2002
CHIN ELECTRODE
K020468 · Dymedix, Inc. · Apr 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
K012463 · Everyway Medical Instruments Co.,Ltd · Feb 2002
KIMSTIM AURICULAR ELECTRODE
K011691 · Kim Institute For Rehabilitation Medicine, P.C. · Dec 2001
K003896 · LYMPHA VISION-EXPERT
Download PDF FDA Summary Bexley Trading, Inc.