Cleared Traditional

DIXI Medical Microdeep Micro-Macro Depth Electrodes (K202087) - FDA 510(k) Clearance

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

K202087 · Dixi Medical · Neurology device
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Nov 2021
Decision
478d
Days
Class 2
Risk

K202087 is an FDA 510(k) clearance for the DIXI Medical Microdeep Micro-Macro Depth Electrodes. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on November 18, 2021 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Dixi Medical devices

Submission Details

510(k) Number K202087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2020
Decision Date November 18, 2021
Days to Decision 478 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
330d slower than avg
Panel avg: 148d · This submission: 478d
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 Consultant

Domecus Consulting Services, LLC
Steve Plymale

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 15
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K202087.
iCE-SG2 Subcutaneous Electrode Kit
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Evo® sEEG System
K222404 · Neuroone Medical Technologies Corp. · Oct 2022
Neuro Omega System, NeuroSmart System
K220553 · Alpha Omega Engineering , Ltd. · Sep 2022
Evo sEEG System
K211367 · Neuroone Medical Technologies Corp. · Sep 2021
iCE-SG Subcutaneous Electrode Arrays
K201678 · Ice Neurosystems, Inc. · Mar 2021
Sterile LeadConfirm
K191739 · Alpha Omega Engineering , Ltd. · Jan 2020