Cleared Traditional

K844097 - CANMED 103 9300 ELECTRODE

K844097 is an FDA 510(k) clearance for CANMED 103 9300 ELECTRODE, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K844097 · Medtronic Vascular · Neurology device

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Dec 1984

Decision

49d

Days

Class 2

Risk

K844097 is an FDA 510(k) clearance for the CANMED 103 9300 ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on December 11, 1984 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.

FDA 510(k) Submission Details - K844097

510(k) Number	K844097 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 23, 1984
Decision Date	December 11, 1984
Days to Decision	49 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

100d faster than avg

Panel avg: 149d · This submission: 49d

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 439

Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K844097.

TENS-AID PREMIUM ELECTRODES

K843964 · Staodynamics, Inc. · Feb 1985

CANMED 103

K844098 · Medtronic Vascular · Feb 1985

AQUAFORM ELECTRODES WITH AQUAPORE

K844023 · Biostim, Inc. · Feb 1985

SIEGEN SURFACE ELECTRODES

K844646 · Siegen Corp. · Dec 1984

ELECTRODE PLACEMENT ARM PART GARMENT

K842033 · Bio-Stimu Trend Corp. · Jul 1984

ELECTRODE, SURFACE EEG ELECTRODE

K842271 · Durden Enterprises, Inc. · Jul 1984

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K844097

Medtronic Vascular

Lawrence, MA · US

ED SHAUGHNESSY

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

View all devices by Medtronic Vascular →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: December 11, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: June 2026.

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