Cleared Traditional

K901441 - ALBERT MORTON UROLOGICAL CATHETER

K901441 is an FDA 510(k) clearance for ALBERT MORTON UROLOGICAL CATHETER, manufactured by Transinternational Marketing Group. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

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

FDA 510(k) Submission Details - K901441

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.

GBM Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K901441.
WALTHER CATHETERS, MALE, FEMALE
K926369 · Thomasville Medical Assoc. · May 1993
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · American Medical Systems, Inc. · Mar 1992
AUTOCATH(TM) SET
K910876 · Cook Urological, Inc. · May 1991
KENDALL CURITY URETHRAL CATHETERS
K892442 · The Kendal Co. · Jun 1989
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
K881667 · The Kendal Co. · Aug 1988
OPEN ENDED URETERAL CATHETER
K830840 · Van-Tec, Inc. · Apr 1983