Cleared Traditional

K052428 - RESOLUTION ENDOVASCULAR SYSTEM

K052428 is an FDA 510(k) clearance for RESOLUTION ENDOVASCULAR SYSTEM, manufactured by Omnisonics Medical Technologies. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K052428 · Omnisonics Medical Technologies · Cardiovascular device
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Dec 2005
Decision
97d
Days
Class 2
Risk

K052428 is an FDA 510(k) clearance for the RESOLUTION ENDOVASCULAR SYSTEM. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Omnisonics Medical Technologies (Wilmington, US). The FDA issued a Cleared decision on December 8, 2005 after a review of 97 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 Omnisonics Medical Technologies devices

FDA 510(k) Submission Details - K052428

510(k) Number K052428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date December 08, 2005
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEY Device Classification - Class 2, Special Controls

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 62
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K052428.
LYSUS INFUSION SYSTEM
K060422 · Ekos Corp. · Mar 2006
LYSUS INFUSION SYSTEM
K060084 · Ekos Corp. · Feb 2006
EKOS MICRO-INFUSION SYSTEM
K053432 · Ekos Corp. · Dec 2005
LYSUS INFUSION SYSTEM
K052071 · Ekos Corp. · Aug 2005
LYSUS INFUSION SYSTEM
K051319 · Ekos Corp. · Jun 2005
EKOS PERIPHERAL INFUSION SYSTEM
K050563 · Ekos Corp. · Mar 2005