Cleared Traditional

K894911 - SENSORY NEEDLE ELECTRODE DNE 111-115

K894911 is the FDA 510(k) clearance for SENSORY NEEDLE ELECTRODE DNE 111-115 by Dantec Electronics, Inc.. It is a Class 2 Neurology device (product code GXZ) cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K894911 · Dantec Electronics, Inc. · Neurology device
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May 1990
Decision
286d
Days
Class 2
Risk

K894911 is an FDA 510(k) clearance for the SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on May 14, 1990 after a review of 286 days - an extended review cycle.

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: 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 Dantec Electronics, Inc. devices

Submission Details

510(k) Number K894911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date May 14, 1990
Days to Decision 286 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 148d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.