Cleared Traditional

K052611 - ECP HEALTH SYSTEM, MODEL 2005

K052611 is an FDA 510(k) clearance for ECP HEALTH SYSTEM, manufactured by Ecp Health, Inc.. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K052611 · Ecp Health, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
216d
Days
Class 2
Risk

K052611 is an FDA 510(k) clearance for the ECP HEALTH SYSTEM, MODEL 2005. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Ecp Health, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 26, 2006 after a review of 216 days - an extended review cycle.

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

FDA 510(k) Submission Details - K052611

510(k) Number K052611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2005
Decision Date April 26, 2006
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 25
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K052611.
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
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CIRCULATOR BOOT
K082134 · Circulator Boot Corp. · May 2009
GENESIS ECP
K081359 · Scottcare Corporation · May 2008
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
K050172 · Cardiomedics, Inc. · Mar 2005
ACS MODEL NCP-2
K042413 · Applied Cardiac Systems · Dec 2004
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · S-Tct Health, Inc. · May 2003