Cleared Abbreviated

COBE REVOLUTION (K011835) - FDA 510(k) Clearance

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

K011835 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
245d
Days
Class 2
Risk

K011835 is an FDA 510(k) clearance for the COBE REVOLUTION. 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 February 12, 2002 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cobe Cardiovascular, Inc. devices

Submission Details

510(k) Number K011835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date February 12, 2002
Days to Decision 245 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Standards-based clearance path.

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 25
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K011835.
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · Medtronic, Inc. · Jun 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
CAPIOX SP PUMP HEAD
K962981 · Terumo Medical Corp. · Feb 1997
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · Baxter Healthcare Corp · Apr 1996
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · 3M Company · Dec 1990