Cleared Special

K200648 - EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

K200648 is an FDA 510(k) clearance for EKOS PE Endovascular Device with Contro..., manufactured by Ekos Corporation. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Special 510(k) pathway after a 158-day FDA review.

K200648 · Ekos Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
158d
Days
Class 2
Risk

K200648 is an FDA 510(k) clearance for the EKOS PE Endovascular Device with Control System 4.0 (CS4.0). Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Ekos Corporation (Bothell, US). The FDA issued a Cleared decision on August 17, 2020 after a review of 158 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200648

510(k) Number K200648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date August 17, 2020
Days to Decision 158 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
33d slower than avg
Panel avg: 125d · This submission: 158d
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 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K200648.
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K200648 · EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
Download PDF FDA Summary Ekos Corporation