Cleared Traditional

K032068 - CARDIOVENTION CORX IOS-200 SYSTEM

K032068 is the FDA 510(k) clearance for CARDIOVENTION CORX IOS-200 SYSTEM by Cardiovention, Inc.. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K032068 · Cardiovention, Inc. · Cardiovascular device
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Aug 2003
Decision
50d
Days
Class 2
Risk

K032068 is an FDA 510(k) clearance for the CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Cardiovention, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 Cardiovention, Inc. devices

Submission Details

510(k) Number K032068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2003
Decision Date August 22, 2003
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 77
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K032068.
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
K072583 · Maquet Cardiopulmonary, AG · Apr 2008
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
K041979 · Quest Medical, Inc. · Sep 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
K040355 · Gish Biomedical, Inc. · Mar 2004
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · Cobe Cardiovascular, Inc. · Jul 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · Gish Biomedical, Inc. · Apr 2002
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · Cobe Cardiovascular, Inc. · Sep 2001