Cleared Traditional

K102842 - ADHESIVE ELECTRODES

K102842 is an FDA 510(k) clearance for ADHESIVE ELECTRODES, manufactured by Reno Medical Limited. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K102842 · Reno Medical Limited · Neurology device
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Dec 2010
Decision
64d
Days
Class 2
Risk

K102842 is an FDA 510(k) clearance for the ADHESIVE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Reno Medical Limited (Shanghai, CN). The FDA issued a Cleared decision on December 2, 2010 after a review of 64 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 Reno Medical Limited devices

FDA 510(k) Submission Details - K102842

510(k) Number K102842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date December 02, 2010
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
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 237
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K102842.
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