Cleared Traditional

K041629 - LYSUS INFUSION SYSTEM

K041629 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 Traditional 510(k) pathway after a 51-day FDA review.

K041629 · Ekos Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
51d
Days
Class 2
Risk

K041629 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 August 6, 2004 after a review of 51 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. 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 Ekos Corp. devices

FDA 510(k) Submission Details - K041629

510(k) Number K041629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date August 06, 2004
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 46
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K041629.
EKOS PERIPHERAL INFUSION SYSTEM
K050563 · Ekos Corp. · Mar 2005
Lysus Infusion System
K043269 · Ekos Corp. · Dec 2004
Lysus Infusion System
K042456 · Ekos Corp. · Sep 2004
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc. · Nov 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · Ekos Corp. · Oct 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · Ekos Corp. · Jul 2003