Cleared Traditional

K120098 - STERILE DISPOSABLES FOR MER

K120098 is an FDA 510(k) clearance for STERILE DISPOSABLES FOR MER, 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 152-day FDA review.

K120098 · Alpha Omega Engineering , Ltd. · Neurology device
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Jun 2012
Decision
152d
Days
Class 2
Risk

K120098 is an FDA 510(k) clearance for the STERILE DISPOSABLES FOR MER. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega Engineering , Ltd. (Zichron Yaacov, IL). The FDA issued a Cleared decision on June 12, 2012 after a review of 152 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 - K120098

510(k) Number K120098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2012
Decision Date June 12, 2012
Days to Decision 152 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 149d · This submission: 152d
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.

Regulatory Peers - GZL Electrode, Depth

All 54
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