Cleared Traditional

K842553 - CHESEBROUGH-POND'S REUSABLE URINARY LEG

K842553 is an FDA 510(k) clearance for CHESEBROUGH-POND'S REUSABLE URINARY LEG, manufactured by Chesebrough-Pond'S U.S.A. Co.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K842553

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 131d · This submission: 18d
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 100
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
CYSTO-AID
K841197 · E-Z-Em, Inc. · Jul 1984
CURITY RIG FOLEY CATH TRAY
K841169 · The Kendal Co. · Jul 1984
URETHRAL CATH. TRAY W/BAG
K840292 · Corpak Co. · Mar 1984