Cleared Traditional

K182757 - Espire Elbow Pro, Espire Elbow Hybrid (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182757 · College Park Industries, Inc. · Neurology device
Nov 2018
Decision
62d
Days
Class 2
Risk

K182757 is an FDA 510(k) clearance for the Espire Elbow Pro, Espire Elbow Hybrid. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by College Park Industries, Inc. (Warren, US). The FDA issued a Cleared decision on November 29, 2018 after a review of 62 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.

Submission Details

510(k) Number K182757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date November 29, 2018
Days to Decision 62 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 163d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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