Cleared Traditional

K033617 - EECP THERAPY SYSTEM MODEL TS4 WITH/WITH...

K033617 is the FDA 510(k) clearance for EECP THERAPY SYSTEM MODEL TS4 WITH/WITH... by Vasomedical, Inc.. It is a Class 2 Cardiovascular device (product code DRN) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K033617 · Vasomedical, Inc. · Cardiovascular device
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Mar 2004
Decision
104d
Days
Class 2
Risk

K033617 is an FDA 510(k) clearance for the EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Vasomedical, Inc. (Westbury, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 104 days - within the typical 510(k) review window.

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 Vasomedical, Inc. devices

Submission Details

510(k) Number K033617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2003
Decision Date March 01, 2004
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.