Cleared Traditional

NEUROPLUS, MODEL A10040, A10041, A10042, A10043 (K010638) - FDA 510(k) Clearance

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

K010638 · Vermont Medical, Inc. · Neurology device
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May 2001
Decision
59d
Days
Class 2
Risk

K010638 is an FDA 510(k) clearance for the NEUROPLUS, MODEL A10040, A10041, A10042, A10043. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vermont Medical, Inc. devices

Submission Details

510(k) Number K010638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date May 03, 2001
Days to Decision 59 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
89d faster than avg
Panel avg: 148d · This submission: 59d
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 98
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K010638.
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TENZCARE ELECTRODE 6862
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STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988