Cleared Traditional

K823716 - CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC

K823716 is an FDA 510(k) clearance for CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823716 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Jan 1983
Decision
35d
Days
Class 2
Risk

K823716 is an FDA 510(k) clearance for the CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 35 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 Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K823716

510(k) Number K823716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date January 14, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 131d · This submission: 35d
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 102
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K823716.
URINE BAG SYSTEM
K831796 · I M, Inc. · Aug 1983
LEG DRAINAGE BAG STRAP BK6011
K831553 · Fred Sammons, Inc. · Jun 1983
CURITY LEG BAG
K831121 · The Kendal Co. · Apr 1983
PEDIATRIC URINE COLLECTOR
K823411 · Sage Products, Inc. · Dec 1982
ADHESIVE SPRAY #4050-4060
K822307 · The Healthcare Group Laboratories, Inc. · Sep 1982
STERILE FOLEY CATHETERIZATION KITS
K821979 · Medical Devices, Inc. · Aug 1982