Cleared Traditional

K053214 - THERAKNIT GARMENT ELECTRODE

K053214 is an FDA 510(k) clearance for THERAKNIT GARMENT ELECTRODE, manufactured by Neurotron Medical. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K053214 · Neurotron Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
33d
Days
Class 2
Risk

K053214 is an FDA 510(k) clearance for the THERAKNIT GARMENT ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Neurotron Medical (Ewing, US). The FDA issued a Cleared decision on December 20, 2005 after a review of 33 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 - K053214

510(k) Number K053214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date December 20, 2005
Days to Decision 33 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 149d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

All 409
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K053214.
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K053626 · Neuro Resource Group, Inc. · Mar 2006
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K052875 · Summit Manufacturing, LLC · Dec 2005
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC · Aug 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
EZ-STIK ELECTRODES
K050469 · Naimco, Inc. · May 2005
K053214 · THERAKNIT GARMENT ELECTRODE
Download PDF FDA Summary Neurotron Medical