Cleared Special

K012209 - CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X

K012209 is an FDA 510(k) clearance for CAPIOX SP PUMP WITH X-COATING PRODUCT C..., 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 30-day FDA review.

K012209 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Aug 2001
Decision
30d
Days
Class 2
Risk

K012209 is an FDA 510(k) clearance for the CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X. 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 August 15, 2001 after a review of 30 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 - K012209

510(k) Number K012209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 15, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K012209.
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393 · A-Med Systems, Inc. · Nov 2001
AB-180 XC SYSTEM, MODEL AB-180XC
K991783 · Cardiacassist, Inc. · Nov 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · Jostra Medizintechnik AG · Aug 2000
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
K992592 · A-Med Systems, Inc. · May 2000