Cleared Traditional

K971764 - WELCON HUE-VU URINARY DRAINAGE BAG

K971764 is the FDA 510(k) clearance for WELCON HUE-VU URINARY DRAINAGE BAG by Welcon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K971764 · Welcon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
77d
Days
Class 2
Risk

K971764 is an FDA 510(k) clearance for the WELCON HUE-VU URINARY DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 77 days - a notably fast clearance cycle.

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: 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 Welcon, Inc. devices

Submission Details

510(k) Number K971764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1997
Decision Date July 29, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
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 81
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K971764.
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · Medline Industries, Inc. · Dec 1997
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
K962652 · Customed, Inc. · Oct 1996
PROSYS LEG BAG
K952208 · Convatec, A Division of E.R. Squibb & Sons · Aug 1995
NEEDLELESS URINE SAMPLING PORT
K944236 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993