Cleared Traditional

K842553 - CHESEBROUGH-POND'S REUSABLE URINARY LEG

K842553 is the FDA 510(k) clearance for CHESEBROUGH-POND'S REUSABLE URINARY LEG 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 18-day FDA review.

K842553 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
18d
Days
Class 2
Risk

K842553 is an FDA 510(k) clearance for the CHESEBROUGH-POND'S REUSABLE URINARY LEG. 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. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1984 after a review of 18 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K842553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date July 20, 1984
Days to Decision 18 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
112d faster than avg
Panel avg: 130d · This submission: 18d
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 42
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K842553.
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
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE
K832290 · Travenol Laboratories, S.A. · Jul 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · Coloplast A/S · Jan 1984
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · Medline Industries, Inc. · Oct 1983