Cleared Traditional

K944267 - HEAT EXCHANGER MODIFICATION FOR DUO AND...

K944267 is an FDA 510(k) clearance for HEAT EXCHANGER MODIFICATION FOR DUO AND..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K944267 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
239d
Days
Class 2
Risk

K944267 is an FDA 510(k) clearance for the HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on April 28, 1995 after a review of 239 days - an extended review 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: 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K944267

510(k) Number K944267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date April 28, 1995
Days to Decision 239 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
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K944267.
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571 · Lifestream Int'L, Inc. · Aug 1997
MYOCARDIAL PROTECTION SYSTEM
K953838 · Quest Medical, Inc. · Mar 1996
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · Gish Biomedical, Inc. · Jun 1995
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · Electromedics, Inc. · Dec 1993
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993
HE-30 GOLD
K931967 · Bentley Laboratories, Inc. · Jul 1993