Cleared Traditional

K081279 - PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000

K081279 is an FDA 510(k) clearance for PRO-TECH DELIVERY SYSTEM ELECTRODES, manufactured by Transfer Technology. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K081279 · Transfer Technology · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2009
Decision
262d
Days
Class 2
Risk

K081279 is an FDA 510(k) clearance for the PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Transfer Technology (Murrieta, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 262 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transfer Technology devices

FDA 510(k) Submission Details - K081279

510(k) Number K081279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2008
Decision Date January 23, 2009
Days to Decision 262 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 148d · This submission: 262d
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 244
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K081279.
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