Cleared Traditional

M & R DISPOSABLE ELECTRODE (14200) (K963236) - FDA 510(k) Clearance

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

K963236 · M & R Mfg., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
88d
Days
Class 2
Risk

K963236 is an FDA 510(k) clearance for the M & R DISPOSABLE ELECTRODE (14200). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by M & R Mfg., Inc. (Fredericktown, US). The FDA issued a Cleared decision on November 15, 1996 after a review of 88 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 M & R Mfg., Inc. devices

Submission Details

510(k) Number K963236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date November 15, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 436
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K963236.
BioWave BioWraps
K261522 · Biowave Corporation · Jun 2026
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
K253237 · Elde Medikal Sanayi ve Ticaret Anonim Sirketi · May 2026
MR Conditional Cup Electrodes
K254183 · Technomed Europe · May 2026
Tutamen Self Adhesive Electrodes
K252439 · Dongguan Tutamen Metalwork Co., Ltd. · May 2026
myosmart. (13E522)
K253256 · Otto Bock Healthcare Products GmbH · Apr 2026
Ceribell Brain Monitor Headband
K260363 · Ceribell, Inc. · Apr 2026