Cleared Traditional

K132712 - AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

K132712 is an FDA 510(k) clearance for AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K132712 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
82d
Days
Class 2
Risk

K132712 is an FDA 510(k) clearance for the AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on November 19, 2013 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K132712

510(k) Number K132712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2013
Decision Date November 19, 2013
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 76
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K132712.
Revolution Centrifugal Blood Pump
K190650 · Sorin Group Italia S.R.L. · Aug 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · Cardiacassist, Inc. · Jul 2019
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · International Biophysics Corporation · Dec 2017
QUADROX-IR ADULT AND SMALL ADULT
K133265 · Maquet Cardiopulmonary, AG · Nov 2013
SARN CENTRIFUGAL PUMP
K112229 · Terumo Cardiovascular Systems · Dec 2011
TANDEMHEART PUMP
K110493 · Cardiacassist, Inc. · Sep 2011
K132712 · AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
Download PDF FDA Summary Medtronic, Inc.