Cleared Traditional

K802875 - ARGYLE HEMATURIA BALLOON CATHETER

K802875 is the FDA 510(k) clearance for ARGYLE HEMATURIA BALLOON CATHETER by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K802875 · Sherwood Medical Co. · Gastroenterology & Urology device
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Dec 1980
Decision
29d
Days
Class 2
Risk

K802875 is an FDA 510(k) clearance for the ARGYLE HEMATURIA BALLOON CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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

Submission Details

510(k) Number K802875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date December 16, 1980
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K802875.
CLOSED SYSTEM URETHRAL CATHETERIZ. SET
K803259 · Medical Devices, Inc. · Jan 1981
FOLEY CATHETER
K803079 · American Hospital Supply Corp. · Dec 1980
ALL PUPOSE URETHRAL CATHETER
K803080 · American Hospital Supply Corp. · Dec 1980
FOLEY CATHETER
K802516 · Abco Dealers, Inc. · Oct 1980
FOLEY CATHETERIZATION TRAY
K801820 · Abco Dealers, Inc. · Oct 1980
LATEX FOLEY CATHETER (HYDROMER COATED)
K801415 · G.D. Searle and Co. · Aug 1980