Cleared Traditional

K101839 - KANEKA PHARMA AMERICA XPRESS-WAY RX

K101839 is the FDA 510(k) clearance for KANEKA PHARMA AMERICA XPRESS-WAY RX by Kaneka Pharma America, LLC. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K101839 · Kaneka Pharma America, LLC · Cardiovascular device
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Oct 2010
Decision
113d
Days
Class 2
Risk

K101839 is an FDA 510(k) clearance for the KANEKA PHARMA AMERICA XPRESS-WAY RX. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Kaneka Pharma America, LLC (Hudson, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Kaneka Pharma America, LLC devices

Submission Details

510(k) Number K101839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date October 22, 2010
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 51
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K101839.
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K073627 · Cook, Inc. · Mar 2008