Cleared Traditional

K843128 - FEMALE URINARY INCONTINENCE SYS

K843128 is the FDA 510(k) clearance for FEMALE URINARY INCONTINENCE SYS by Chesebrough-Pond'S U.S.A. Co.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K843128 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology device
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Jan 1985
Decision
146d
Days
Class 2
Risk

K843128 is an FDA 510(k) clearance for the FEMALE URINARY INCONTINENCE SYS. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 146 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K843128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date January 02, 1985
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
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 41
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K843128.
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684 · Coloplast A/S · Jan 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984
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