Cleared Traditional

K052527 - NEUROPROBES

K052527 is an FDA 510(k) clearance for NEUROPROBES, manufactured by Alpha Omega Engineering , Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K052527 · Alpha Omega Engineering , Ltd. · Neurology device
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Apr 2006
Decision
212d
Days
Class 2
Risk

K052527 is an FDA 510(k) clearance for the NEUROPROBES. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega Engineering , Ltd. (Nazareth Illit, IL). The FDA issued a Cleared decision on April 12, 2006 after a review of 212 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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 Alpha Omega Engineering , Ltd. devices

FDA 510(k) Submission Details - K052527

510(k) Number K052527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2005
Decision Date April 12, 2006
Days to Decision 212 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
64d slower than avg
Panel avg: 148d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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.