Cleared Traditional

K963236 - M & R DISPOSABLE ELECTRODE (14200)

K963236 is an FDA 510(k) clearance for M & R DISPOSABLE ELECTRODE (14200), manufactured by M & R Mfg., Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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

FDA 510(k) Submission Details - K963236

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
Combination Product No
PCCP Authorized No
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.

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 273
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K963236.
MEDICOM, TENS ELECTRODES
K965194 · Medicotest A/S · Mar 1997
AQUABOND ELECTRODE
K964433 · Medibond , Ltd. · Jan 1997
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · Aspect Medical Systems, Inc. · Oct 1996
EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K961141 · Uni-Patch, Inc. · May 1996
MODEL 1220, OR E-NET (54-62 CM)
K961609 · Physiometrix, Inc. · May 1996