Cleared Traditional

EXTERNAL MALE CATHETER (K852051) - FDA 510(k) Clearance

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

K852051 · Buffalo Medical Specialties Mfg., Inc. · Gastroenterology & Urology device
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Aug 1985
Decision
105d
Days
Class 2
Risk

K852051 is an FDA 510(k) clearance for the EXTERNAL MALE CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Buffalo Medical Specialties Mfg., Inc. (Clearwater, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 105 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 Buffalo Medical Specialties Mfg., Inc. devices

Submission Details

510(k) Number K852051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date August 22, 1985
Days to Decision 105 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
25d faster than avg
Panel avg: 130d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 205
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K852051.
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · Medline Industries, Inc. · Dec 1997
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984