Cleared Traditional

K800505 - URETHRAL CATHETER

K800505 is an FDA 510(k) clearance for URETHRAL CATHETER, manufactured by Medi-Craft , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K800505 · Medi-Craft , Ltd. · Gastroenterology & Urology device
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Apr 1980
Decision
35d
Days
Class 2
Risk

K800505 is an FDA 510(k) clearance for the URETHRAL CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Medi-Craft , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 35 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.

FDA 510(k) Submission Details - K800505

510(k) Number K800505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date April 08, 1980
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

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 164
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K800505.
LATEX FOLEY CATHETER (HYDROMER COATED)
K801415 · G.D. Searle and Co. · Aug 1980
URINARY CATHETERS #3400,3410 &3420
K801784 · The Healthcare Group Laboratories, Inc. · Aug 1980
CATHETER STYLET
K800609 · G.D. Searle and Co. · Apr 1980
FOLEY CATHETER
K800306 · Abco Dealers, Inc. · Feb 1980
IRRIGATION (3-WAY) FOLEY CATHETER
K800307 · Abco Dealers, Inc. · Feb 1980
PEDIATRIC FOLEY CATHETER
K800308 · Abco Dealers, Inc. · Feb 1980