Cleared Special

K081359 - GENESIS ECP

K081359 is an FDA 510(k) clearance for GENESIS ECP, manufactured by Scottcare Corporation. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Special 510(k) pathway after a 14-day FDA review.

K081359 · Scottcare Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
14d
Days
Class 2
Risk

K081359 is an FDA 510(k) clearance for the GENESIS ECP. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Scottcare Corporation (Cleveland, US). The FDA issued a Cleared decision on May 29, 2008 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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.

FDA 510(k) Submission Details - K081359

510(k) Number K081359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2008
Decision Date May 29, 2008
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

DRN Device Classification - Class 2, Special Controls

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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 - DRN Device, Counter-pulsating, External

All 28
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K081359.
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ACS MODEL NCP-2
K042413 · Applied Cardiac Systems · Dec 2004