Cleared Special

K030462 - COBE REVOLUTION CENTRIFUGAL BLOOD PUMP ...

K030462 is an FDA 510(k) clearance for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP ..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Special 510(k) pathway after a 22-day FDA review.

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

FDA 510(k) Submission Details - K030462

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

KFM Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K030462.
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072 · Maquet Cardiopulmonary, AG · May 2006
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109 · Medtronic Perfusion Systems · Feb 2005
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc. · May 2003
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp. · Aug 2001