Cleared Traditional

PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (K033730) - FDA 510(k) Clearance

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

K033730 · Pmt Corp. · Neurology device
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Aug 2004
Decision
249d
Days
Class 2
Risk

K033730 is an FDA 510(k) clearance for the PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 249 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 Pmt Corp. devices

Submission Details

510(k) Number K033730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2003
Decision Date August 03, 2004
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 148d · This submission: 249d
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 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K033730.
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SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023