Cleared Traditional

K862028 - ULTRAHESIVE II POSTOP ELECTRODE

K862028 is an FDA 510(k) clearance for ULTRAHESIVE II POSTOP ELECTRODE, 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 65-day FDA review.

K862028 · Medical Devices, Inc. · Neurology device
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Aug 1986
Decision
65d
Days
Class 2
Risk

K862028 is an FDA 510(k) clearance for the ULTRAHESIVE II POSTOP ELECTRODE. 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 August 1, 1986 after a review of 65 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 - K862028

510(k) Number K862028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date August 01, 1986
Days to Decision 65 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
83d faster than avg
Panel avg: 148d · This submission: 65d
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 K862028.
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · Valleylab, Inc. · Sep 1986
VERSA STIM
K862718 · Conmedcorp · Sep 1986
EMPI, MODEL 1000 HAND HELD ELECTRODE
K862231 · Empi · Aug 1986
JELTRODE
K861956 · Henley Intl. · Jun 1986
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi · Dec 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · Medical Devices, Inc. · Jun 1985