Cleared Traditional

K914384 - MEDICAL DESIGNS REUSABLE CARBON RUBBER ...

K914384 is the FDA 510(k) clearance for MEDICAL DESIGNS REUSABLE CARBON RUBBER ... by Medical Design & Manufacturing Corp.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K914384 · Medical Design & Manufacturing Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
43d
Days
Class 2
Risk

K914384 is an FDA 510(k) clearance for the MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medical Design & Manufacturing Corp. (Westerville, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 43 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 Medical Design & Manufacturing Corp. devices

Submission Details

510(k) Number K914384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date November 13, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
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 153
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K914384.
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · Conmedcorp · Jun 1994
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co. · Dec 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
TBD TENS REUSABLE ELECTRODE
K902195 · Empi · Jun 1990
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990