Cleared Traditional

EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (K033617) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033617 · Vasomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - DRN Device, Counter-pulsating, External

All 33
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K033617.
Pression Wave PRO External Counter-Pulsation System
K250756 · Pression, Inc. · Dec 2025
External Counterpulsation System, Soulaire
K202108 · Vamed Medical Instrument Co., Ltd. · Aug 2020
Enhanced External Counter Pulsation Device Plus Omay-A
K191955 · Omay(Guangzhou)Med Technologies Co., Ltd. · Aug 2020
External Counterpulsation System
K190683 · Vamed Medical Instrument Co., Ltd. · Sep 2019
Pure Flow External Counter-Pulsation Device
K173483 · Xtreem Pulse, LLC · May 2018