Cleared Traditional

K802878 - K-KATH URETHRAL CATHETER INTRODUCER

K802878 is an FDA 510(k) clearance for K-KATH URETHRAL CATHETER INTRODUCER, manufactured by B&K Medical. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K802878 · B&K Medical · Gastroenterology & Urology device
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Jan 1981
Decision
46d
Days
Class 2
Risk

K802878 is an FDA 510(k) clearance for the K-KATH URETHRAL CATHETER INTRODUCER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by B&K Medical (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981 after a review of 46 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 B&K Medical devices

FDA 510(k) Submission Details - K802878

510(k) Number K802878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date January 02, 1981
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
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 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K802878.
SILICONE ELASTOMER COATED LATEX FOLEY
K810630 · G.D. Searle and Co. · Mar 1981
ARGYLE ROB-NELS
K810216 · Sherwood Medical Co. · Feb 1981
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
ARGYLE HEMATURIA BALLOON CATHETER
K802875 · Sherwood Medical Co. · Dec 1980