Cleared Traditional

K030637 - EKOS PERIPHERAL INFUSION SYSTEM

K030637 is an FDA 510(k) clearance for EKOS PERIPHERAL 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 144-day FDA review.

K030637 · Ekos Corp. · Cardiovascular device
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Jul 2003
Decision
144d
Days
Class 2
Risk

K030637 is an FDA 510(k) clearance for the EKOS PERIPHERAL 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 July 22, 2003 after a review of 144 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 Ekos Corp. devices

FDA 510(k) Submission Details - K030637

510(k) Number K030637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date July 22, 2003
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 K030637.
LYSUS INFUSION SYSTEM
K041629 · Ekos Corp. · Aug 2004
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc. · Nov 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · Ekos Corp. · Oct 2003
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · Merit Medical Systems, Inc. · Jul 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · Merit Medical Systems, Inc. · Jun 1999
Squirt Fluid Delivery System
K981417 · Merit Medical Systems, Inc. · Jul 1998