Cleared Traditional

K852051 - EXTERNAL MALE CATHETER

K852051 is an FDA 510(k) clearance for EXTERNAL MALE CATHETER, manufactured by Buffalo Medical Specialties Mfg., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K852051

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
26d faster than avg
Panel avg: 131d · This submission: 105d
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 K852051.
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
URI-CATH SYSTEM
K852490 · Gesco Intl., Inc. · Nov 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · Holter-Hausner Intl. · Aug 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · The Kendal Co. · Aug 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
K851470 · Lic-Orthion · Jun 1985