Cleared Traditional

K943449 - NEUROLOGICAL DIAGNOSTIC DEVICES

K943449 is an FDA 510(k) clearance for NEUROLOGICAL DIAGNOSTIC DEVICES, manufactured by Henley Intl.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 485-day FDA review.

K943449 · Henley Intl. · Neurology device
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Nov 1995
Decision
485d
Days
Class 2
Risk

K943449 is an FDA 510(k) clearance for the NEUROLOGICAL DIAGNOSTIC DEVICES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on November 15, 1995 after a review of 485 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: 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.

View all Henley Intl. devices

FDA 510(k) Submission Details - K943449

510(k) Number K943449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date November 15, 1995
Days to Decision 485 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
337d slower than avg
Panel avg: 148d · This submission: 485d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 294
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K943449.
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K950782 · Graphic Controls Corp. · Jun 1995