Cleared Traditional

K851175 - TRANSCUTANEOUS ELECTRICAL NERVE STIMULA...

K851175 is an FDA 510(k) clearance for TRANSCUTANEOUS ELECTRICAL NERVE STIMULA..., manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K851175 · Medical Devices, Inc. · Neurology device
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Jun 1985
Decision
85d
Days
Class 2
Risk

K851175 is an FDA 510(k) clearance for the TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Devices, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 18, 1985 after a review of 85 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K851175

510(k) Number K851175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1985
Decision Date June 18, 1985
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
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 157
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K851175.
ULTRAHESIVE II POSTOP ELECTRODE
K862028 · Medical Devices, Inc. · Aug 1986
JELTRODE
K861956 · Henley Intl. · Jun 1986
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi · Dec 1985
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984