Cleared Traditional

K844684 - COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM

K844684 is an FDA 510(k) clearance for COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM, manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K844684 · Coloplast A/S · Gastroenterology & Urology device
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Jan 1985
Decision
39d
Days
Class 2
Risk

K844684 is an FDA 510(k) clearance for the COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Coloplast A/S (Tampa, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 39 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 Coloplast A/S devices

FDA 510(k) Submission Details - K844684

510(k) Number K844684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date January 08, 1985
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
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 94
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K844684.
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
K851470 · Lic-Orthion · Jun 1985
TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
K851471 · Lic-Orthion · Jun 1985
ULTRA EXTERNAL CATHETER
K844801 · Inmed Corp. · Jan 1985
FEMALE URINARY INCONTINENCE SYS
K843128 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984
PHARMA-PLAST URIDROP-URIDOME
K843478 · Zimmar Consulting , Ltd. · Dec 1984