Cleared Traditional

K191077 - Affinity CP Centrifugal Blood Pump

K191077 is the FDA 510(k) clearance for Affinity CP Centrifugal Blood Pump by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K191077 · Medtronic, Inc. · Cardiovascular device
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Aug 2019
Decision
126d
Days
Class 2
Risk

K191077 is an FDA 510(k) clearance for the Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with B.... Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 27, 2019 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K191077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2019
Decision Date August 27, 2019
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K191077.
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K202169 · Qura S.R.L · Sep 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
K201068 · Medtronic, Inc. · May 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K192850 · Qura S.R.L · Apr 2020
Revolution Centrifugal Blood Pump
K190650 · Sorin Group Italia S.R.L. · Aug 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · Cardiacassist, Inc. · Jul 2019
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712 · Medtronic, Inc. · Nov 2013