Cleared Traditional

K950314 - DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)

K950314 is an FDA 510(k) clearance for DANTEC MONOPOLAR LUMEN ELECTRODE (13R18..., manufactured by Dantec Medical, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K950314 · Dantec Medical, Inc. · Neurology device
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Mar 1996
Decision
424d
Days
Class 2
Risk

K950314 is an FDA 510(k) clearance for the DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19). Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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.

FDA 510(k) Submission Details - K950314

510(k) Number K950314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1995
Decision Date March 25, 1996
Days to Decision 424 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
275d slower than avg
Panel avg: 149d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 46
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K950314.
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed · Oct 1999
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 1999
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · Jack'S Electrodes · Jan 1998
PROTECTRODE SYSTEM
K926094 · The Electrode Store, Inc. · Dec 1995
AGRAM SPYRAL ELECTRODE
K934779 · Agram Export-Import Co. · Mar 1995
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994