Cleared Special

K013393 - HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM

Also marketed or referenced as:
MODEL #CP-1H

K013393 is an FDA 510(k) clearance for HEPARIN COATED MINIATURE CENTRIFUGAL BY..., manufactured by A-Med Systems, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Special 510(k) pathway after a 25-day FDA review.

K013393 · A-Med Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
25d
Days
Class 2
Risk

K013393 is an FDA 510(k) clearance for the HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by A-Med Systems, Inc. (West Sacramento, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 25 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.

FDA 510(k) Submission Details - K013393

510(k) Number K013393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date November 09, 2001
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 83
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K013393.
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325 · Cardiovention, Inc. · Apr 2002
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
AB-180 XC SYSTEM, MODEL AB-180XC
K991783 · Cardiacassist, Inc. · Nov 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · Jostra Medizintechnik AG · Aug 2000
K013393 · HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
Download PDF FDA Summary A-Med Systems, Inc.