Cleared Traditional

S2MEDIAN (K832295) - FDA 510(k) Clearance

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

K832295 · Anstek Corp. · Neurology device
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Aug 1983
Decision
49d
Days
Class 2
Risk

K832295 is an FDA 510(k) clearance for the S2MEDIAN. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Anstek Corp. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 49 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 Anstek Corp. devices

Submission Details

510(k) Number K832295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date August 31, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
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 93
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K832295.
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · 3M Company · May 1983
ELECTRODE 3799
K831046 · Medtronic Vascular · Apr 1983
MODEL 3854 ELECTRODE
K820876 · Medtronic Vascular · Apr 1982