Cleared Special

K020998 - SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X

K020998 is an FDA 510(k) clearance for SARNS CENTRIFUGAL PUMP WITH XCOATING, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Special 510(k) pathway after a 7-day FDA review.

K020998 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
7d
Days
Class 2
Risk

K020998 is an FDA 510(k) clearance for the SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 7 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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K020998

510(k) Number K020998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date April 04, 2002
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 74
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K020998.
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc. · Mar 2003
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529 · A-Med Systems, Inc. · Aug 2002
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325 · Cardiovention, Inc. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393 · A-Med Systems, Inc. · Nov 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp. · Aug 2001