Cleared Traditional

K022107 - CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

K022107 is an FDA 510(k) clearance for CARDIASSIST COUNTERPULSATION SYSTEM, manufactured by Cardiomedics, Inc.. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K022107 · Cardiomedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
41d
Days
Class 2
Risk

K022107 is an FDA 510(k) clearance for the CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Cardiomedics, Inc. (Irvine, US). The FDA issued a Cleared decision on August 8, 2002 after a review of 41 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022107

510(k) Number K022107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2002
Decision Date August 08, 2002
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 31
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K022107.
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · Sola Medical Devices, LLC · Jan 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427 · Cardiomedics, Inc. · Jan 2003
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016 · Nicore Equipment & Leasing, Inc. · Dec 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
K020857 · Vasomedical, Inc. · Jun 2002
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K012141 · External Counterpulsation Lab · Oct 2001
CARDIOMEDICS ECP SYSTEM
K010261 · Cardiomedics, Inc. · Feb 2001
K022107 · CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Download PDF FDA Summary Cardiomedics, Inc.