Cleared Traditional

K050172 - CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000

K050172 is an FDA 510(k) clearance for CARDIASSIST COUNTER PULSATION SYSTEM SE..., 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 64-day FDA review.

K050172 · Cardiomedics, Inc. · Cardiovascular device
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Mar 2005
Decision
64d
Days
Class 2
Risk

K050172 is an FDA 510(k) clearance for the CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000. 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 March 31, 2005 after a review of 64 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

FDA 510(k) Submission Details - K050172

510(k) Number K050172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date March 31, 2005
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 8
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K050172.
External Counterpulsation System
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