Cleared Traditional

K151790 - PMT Platinum Depthalon Depth Electrode

K151790 is an FDA 510(k) clearance for PMT Platinum Depthalon Depth Electrode, manufactured by Pmt Corporation. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K151790 · Pmt Corporation · Neurology device
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Jul 2016
Decision
379d
Days
Class 2
Risk

K151790 is an FDA 510(k) clearance for the PMT Platinum Depthalon Depth Electrode. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Pmt Corporation (Chanhassen, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 379 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Pmt Corporation devices

FDA 510(k) Submission Details - K151790

510(k) Number K151790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date July 14, 2016
Days to Decision 379 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
231d slower than avg
Panel avg: 148d · This submission: 379d
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 52
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K151790.
DIXI Medical Microdeep Depth Electrode
K170959 · Dixi Medical · Nov 2017
AccuPoint Electrode
K162459 · Microprobes For Life Science, Inc. Dba Neuron · Jun 2017
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
K163355 · Ad-Tech Medical Instrument Corporation · Apr 2017
DNAP Electrode
K152547 · Ad-Tech Medical Instrument Corporation · Mar 2016
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
K140680 · Alpine Biomed Aps · Dec 2014
NEURO OMEGA SYSTEM
K123796 · Alpha Omega Engineering , Ltd. · Apr 2013