Cleared Traditional

K844023 - AQUAFORM ELECTRODES WITH AQUAPORE

K844023 is an FDA 510(k) clearance for AQUAFORM ELECTRODES WITH AQUAPORE, manufactured by Biostim, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K844023 · Biostim, Inc. · Neurology device
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Feb 1985
Decision
109d
Days
Class 2
Risk

K844023 is an FDA 510(k) clearance for the AQUAFORM ELECTRODES WITH AQUAPORE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Biostim, Inc. (Brooksville, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biostim, Inc. devices

FDA 510(k) Submission Details - K844023

510(k) Number K844023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1984
Decision Date February 01, 1985
Days to Decision 109 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 148d · This submission: 109d
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 315
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K844023.
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850108 · Nicolet Biomedical Instruments · Apr 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984
NEURO EASE
K831785 · Andover Medical, Inc. · Jun 1983
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · 3M Company · May 1983