Cleared Traditional

MMG FOLEY CATHETER (K840839) - FDA 510(k) Clearance

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

K840839 · Medical Technologies of Georgia · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
53d
Days
Class 2
Risk

K840839 is an FDA 510(k) clearance for the MMG FOLEY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Medical Technologies of Georgia (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Technologies of Georgia devices

Submission Details

510(k) Number K840839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date April 17, 1984
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 64
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K840839.
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · Abco Dealers, Inc. · Jul 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · C.R. Bard, Inc. · Feb 1984
FOLEY-TEMP
K831567 · Mallinckrodt Critical Care · Aug 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983