Cleared Traditional

CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K022107) - FDA 510(k) Clearance

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

K022107 · Cardiomedics, Inc. · Cardiovascular device
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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.

View all Cardiomedics, Inc. devices

Submission Details

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
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.

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.