Cleared Traditional

K813479 - ARGYLE PEDIATRIC URINE COLLECTOR

K813479 is an FDA 510(k) clearance for ARGYLE PEDIATRIC URINE COLLECTOR, manufactured by Sherwood Medical Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K813479 · Sherwood Medical Co. · Gastroenterology & Urology device
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Jan 1982
Decision
37d
Days
Class 2
Risk

K813479 is an FDA 510(k) clearance for the ARGYLE PEDIATRIC URINE COLLECTOR. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 37 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K813479

510(k) Number K813479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date January 07, 1982
Days to Decision 37 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
94d faster than avg
Panel avg: 131d · This submission: 37d
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 102
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K813479.
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · The Healthcare Group Laboratories, Inc. · May 1982
CURITY BEDSIDE DRAINAGE BAG
K813621 · The Kendal Co. · Feb 1982
HOLLISTER FEMALE URINARY COLLECT SYS
K820234 · Hollister, Inc. · Feb 1982
ARGYLE CLOSED URINARY DRAINAGE SET
K802667 · Sherwood Medical Co. · Dec 1980
BARD MALE EXTERNAL CATHETER
K802433 · C.R. Bard, Inc. · Oct 1980
LEG BAG EXTENSION TUBE
K802606 · Associated Medical Products Co. · Oct 1980