Cleared Traditional

K832290 - CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE

K832290 is the FDA 510(k) clearance for CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K832290 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Jul 1984
Decision
384d
Days
Class 2
Risk

K832290 is an FDA 510(k) clearance for the CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on July 31, 1984 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K832290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date July 31, 1984
Days to Decision 384 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
254d slower than avg
Panel avg: 130d · This submission: 384d
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 64
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K832290.
SUR-FIT NIGHT DRAINAGE CONTAINER SET
K842395 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
ACCUSEAL LEG BAGS & EXTENSION TUBES
K842396 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
URIHESIVE SYS MALE EXTERNAL CATHETER
K842397 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
CYSTO-AID
K841197 · E-Z-Em, Inc. · Jul 1984
CURITY RIG FOLEY CATH TRAY
K841169 · The Kendal Co. · Jul 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984