Cleared Special

K030462 - COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030462 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
22d
Days
Class 2
Risk

K030462 is an FDA 510(k) clearance for the COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cobe Cardiovascular, Inc. devices

Submission Details

510(k) Number K030462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2003
Decision Date March 06, 2003
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 83
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