Cleared Traditional

K011411 - SELF-ADHESIVE ELECTRODES

K011411 is an FDA 510(k) clearance for SELF-ADHESIVE ELECTRODES, manufactured by Pain Management Technologies. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K011411 · Pain Management Technologies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
36d
Days
Class 2
Risk

K011411 is an FDA 510(k) clearance for the SELF-ADHESIVE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Pain Management Technologies (Akron, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 36 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 - K011411

510(k) Number K011411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date June 13, 2001
Days to Decision 36 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
113d faster than avg
Panel avg: 149d · This submission: 36d
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 375
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K011411.
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K011411 · SELF-ADHESIVE ELECTRODES
Download PDF FDA Summary Pain Management Techn…