Cleared Traditional

K120516 - LONG LIFE PADTM

K120516 is an FDA 510(k) clearance for LONG LIFE PADTM, manufactured by Omron Healthcare, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K120516 · Omron Healthcare, Inc. · Neurology device
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May 2012
Decision
86d
Days
Class 2
Risk

K120516 is an FDA 510(k) clearance for the LONG LIFE PADTM. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on May 17, 2012 after a review of 86 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.

View all Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K120516

510(k) Number K120516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date May 17, 2012
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 265
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K120516.
REUSABLE CUTANEOUS ELECTRODE
K121483 · Ampcare, LLC · Oct 2012
DYNATRON THERMOSTIM PROBE-DONE
K120835 · Dynatronics Corporation · Aug 2012
DISPOSABLE ADHESIVE SURFACE ELECTRODE
K120494 · Spes Medica Srl · Jun 2012
ELECTRO-CAP SYSTEM
K112319 · Electro-Cap Intl., Inc. · Jan 2012
THERATRODE
K112312 · Phoenix Medical Devices, Llp · Jan 2012
NEUROTECH RECOVERY
K112934 · Bio-Medical Research, Ltd. · Jan 2012