Cleared Traditional

K854821 - MMG EXTERNAL FEMALE CATHETERS

K854821 is an FDA 510(k) clearance for MMG EXTERNAL FEMALE CATHETERS, manufactured by Medical Technologies of Georgia. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K854821 · Medical Technologies of Georgia · Gastroenterology & Urology device
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Apr 1986
Decision
142d
Days
Class 2
Risk

K854821 is an FDA 510(k) clearance for the MMG EXTERNAL FEMALE CATHETERS. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Medical Technologies of Georgia (Wilbraham, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Technologies of Georgia devices

FDA 510(k) Submission Details - K854821

510(k) Number K854821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date April 24, 1986
Days to Decision 142 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
11d slower than avg
Panel avg: 131d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 103
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K854821.
NORTA (TM) UROBAG
K870504 · Beiersdorf, Inc. · Apr 1987
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · Hollister, Inc. · Aug 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · American Medical Products, Inc. · Apr 1986
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
URI-CATH SYSTEM
K852490 · Gesco Intl., Inc. · Nov 1985