Cleared Traditional

Sterile LeadConfirm (K191739) - FDA 510(k) Clearance

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

K191739 · Alpha Omega Engineering , Ltd. · Neurology device
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Jan 2020
Decision
188d
Days
Class 2
Risk

K191739 is an FDA 510(k) clearance for the Sterile LeadConfirm. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega Engineering , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on January 2, 2020 after a review of 188 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

Submission Details

510(k) Number K191739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2019
Decision Date January 02, 2020
Days to Decision 188 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
40d slower than avg
Panel avg: 148d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 15
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K191739.
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · Dixi Medical · Nov 2021
Evo sEEG System
K211367 · Neuroone Medical Technologies Corp. · Sep 2021
iCE-SG Subcutaneous Electrode Arrays
K201678 · Ice Neurosystems, Inc. · Mar 2021
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation · Aug 2018
NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018