Cleared Traditional

K041243 - DOVER RED RUBBER ROBINSON CATHETER

K041243 is an FDA 510(k) clearance for DOVER RED RUBBER ROBINSON CATHETER, manufactured by Tyco Healthcare. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K041243 · Tyco Healthcare · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
57d
Days
Class 2
Risk

K041243 is an FDA 510(k) clearance for the DOVER RED RUBBER ROBINSON CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on July 7, 2004 after a review of 57 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 - K041243

510(k) Number K041243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2004
Decision Date July 07, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 131d · This submission: 57d
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 234
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K041243.
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
K080878 · Medical Technologies of Georgia, Inc. · Jul 2008
CURE CATHETER CLOSED SYSTEM
K080881 · Cure Medical, LLC · Jun 2008
DOVER ROB-NEL CATHETER
K040897 · Tyco Healthcare · Jul 2004
BARD TIGERTAIL URETERAL CATHETER
K033719 · C.R. Bard, Inc. · Feb 2004
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
K032710 · Apogee Medical, Inc. · Jan 2004
INTERMITTENT URETHRAL CATHETERS
K033023 · Rusch Intl. · Dec 2003
K041243 · DOVER RED RUBBER ROBINSON CATHETER
Download PDF FDA Summary Tyco Healthcare