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)
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.

View all Lorenz Biotech S.P.A. devices

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
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · 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 249
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K080902.
UNIVERSAL ELECTRODES
K083818 · Neurometrix, Inc. · Jan 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
UNIVERSAL ELECTRODES
K081871 · Neurometrix, Inc. · Sep 2008
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc. · Feb 2007
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc. · Dec 2006