Cleared Traditional

DANTEC 13R45 BAR ELECTRODE (K934580) - FDA 510(k) Clearance

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

K934580 · Dantec Medical, Inc. · Neurology device
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Sep 1994
Decision
368d
Days
Class 2
Risk

K934580 is an FDA 510(k) clearance for the DANTEC 13R45 BAR ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on September 26, 1994 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Dantec Medical, Inc. devices

Submission Details

510(k) Number K934580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1993
Decision Date September 26, 1994
Days to Decision 368 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 148d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 95
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K934580.
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TENZCARE ELECTRODE 6862
K893793 · 3M Company · Nov 1989
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988