Cleared Special

K043269 - Lysus Infusion System

K043269 is an FDA 510(k) clearance for Lysus Infusion System, manufactured by Ekos Corp.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Special 510(k) pathway after a 26-day FDA review.

K043269 · Ekos Corp. · Cardiovascular device
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Dec 2004
Decision
26d
Days
Class 2
Risk

K043269 is an FDA 510(k) clearance for the Lysus Infusion System. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Ekos Corp. (Bothell, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ekos Corp. devices

FDA 510(k) Submission Details - K043269

510(k) Number K043269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date December 22, 2004
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 46
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K043269.
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
Lysus Infusion System
K042456 · Ekos Corp. · Sep 2004
LYSUS INFUSION SYSTEM
K041629 · Ekos Corp. · Aug 2004
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc. · Nov 2003