Cleared Traditional

KWIK-FLO URINAL SYSTEM (K781422) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781422 · The Grace Mfg. Co. · Gastroenterology & Urology device
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Sep 1978
Decision
21d
Days
Class 2
Risk

K781422 is an FDA 510(k) clearance for the KWIK-FLO URINAL SYSTEM. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by The Grace Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 21 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 The Grace Mfg. Co. devices

Submission Details

510(k) Number K781422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1978
Decision Date September 07, 1978
Days to Decision 21 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
109d faster than avg
Panel avg: 130d · This submission: 21d
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 19
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K781422.
DYNACOR STERILE CLOSED SYS. DRAINAGE BAG
K791969 · Medline Industries, Inc. · Nov 1979
ARGYLE URINE METER
K790969 · Sherwood Medical Co. · Jun 1979
BK-6021 CONDOM CATHETER HOLDER
K790174 · Fred Sammons, Inc. · Feb 1979
BAG, URINARY, DRAINAGE, 2D9013
K770762 · Travenol Laboratories, S.A. · May 1977