Cleared Traditional

K043254 - PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043254 · Onset Medical Corporation · Gastroenterology & Urology device
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Feb 2005
Decision
78d
Days
Class 2
Risk

K043254 is an FDA 510(k) clearance for the PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Onset Medical Corporation (Mission Viejo, US). The FDA issued a Cleared decision on February 10, 2005 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 Onset Medical Corporation devices

Submission Details

510(k) Number K043254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date February 10, 2005
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 55
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K043254.
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · Urotronic, Inc. · May 2025
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
K220781 · Allwin Medical Devices, Inc. · May 2023
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · Coloplast Corp. · Jun 2020
EQUINOX Balloon Dilatation Catheter
K190612 · Dornier Medtech America, Inc. · Dec 2019