Cleared Abbreviated

K080902 - FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057

Also marketed or referenced as:
FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058

K080902 is an FDA 510(k) clearance for FREMS SSC DISPOSABLE FOAM ELECTRODES, manufactured by Lorenz Biotech S.P.A.. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

K080902 · Lorenz Biotech S.P.A. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
72d
Days
Class 2
Risk

K080902 is an FDA 510(k) clearance for the FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Lorenz Biotech S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on June 13, 2008 after a review of 72 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080902

510(k) Number K080902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2008
Decision Date June 13, 2008
Days to Decision 72 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
77d faster than avg
Panel avg: 149d · This submission: 72d
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 409
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K080902.
DERMABIOSAFE
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DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K073532 · Technomed Europe · May 2008
TARGET STERILE ELECTRODE
K072799 · Vision Quest Industries, Inc. · Apr 2008
K080902 · FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057
Download PDF FDA Summary Lorenz Biotech S.P.A.