Cleared Traditional

ALBERT MORTON UROLOGICAL CATHETER (K901441) - FDA 510(k) Clearance

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

K901441 · Transinternational Marketing Group · Gastroenterology & Urology device
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Jun 1990
Decision
87d
Days
Class 2
Risk

K901441 is an FDA 510(k) clearance for the ALBERT MORTON UROLOGICAL CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Transinternational Marketing Group (Port Of Charleston, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 87 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 Transinternational Marketing Group devices

Submission Details

510(k) Number K901441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date June 22, 1990
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 27
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K901441.
SpeediCath Flex Coude Pro
K180070 · Coloplast · Feb 2018
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
K172278 · Cook Incorporated · Nov 2017
DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
CATHETER, SILICONE FOLEY (BARDEX)
K760093 · C.R. Bard, Inc. · Aug 1976
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K760253 · C.R. Bard, Inc. · Aug 1976
TRAY, FOLEY CATHETER
K760254 · C.R. Bard, Inc. · Aug 1976