Cleared Traditional

K052875 - PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES

K052875 is an FDA 510(k) clearance for PROSTIM REUSABLE NEUROSTIMULATION ELECT..., manufactured by Summit Manufacturing, LLC. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K052875 · Summit Manufacturing, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
76d
Days
Class 2
Risk

K052875 is an FDA 510(k) clearance for the PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Summit Manufacturing, LLC (Great Neck, US). The FDA issued a Cleared decision on December 27, 2005 after a review of 76 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.

FDA 510(k) Submission Details - K052875

510(k) Number K052875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2005
Decision Date December 27, 2005
Days to Decision 76 days
Submission Type Traditional
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
73d faster than avg
Panel avg: 149d · This submission: 76d
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 409
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K052875.
INSPIRSTAR GLOVE ELECTRODE
K061343 · Inspirstar, Inc. · May 2006
RHYTHMLINK DISC ELECTRODES
K061148 · Rhythmlink International, LLC · May 2006
INTERX500 FLEXIBLE ARRAY ELECTRODE
K053626 · Neuro Resource Group, Inc. · Mar 2006
THERAKNIT GARMENT ELECTRODE
K053214 · Neurotron Medical · Dec 2005
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC · Aug 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
K052875 · PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
Download PDF FDA Summary Summit Manufacturing,…