Cleared Traditional

K192850 - Quantum PureFlow Centrifugal Blood Pump...

K192850 is an FDA 510(k) clearance for Quantum PureFlow Centrifugal Blood Pump..., manufactured by Qura S.R.L. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K192850 · Qura S.R.L · Cardiovascular device
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Apr 2020
Decision
193d
Days
Class 2
Risk

K192850 is an FDA 510(k) clearance for the Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Bl.... Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on April 13, 2020 after a review of 193 days - an extended review 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: 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 Qura S.R.L devices

FDA 510(k) Submission Details - K192850

510(k) Number K192850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2019
Decision Date April 13, 2020
Days to Decision 193 days
Submission Type Traditional
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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 43
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K192850.
FloPump 57mL Centrifugal Pump
K193663 · International Biophysics Corporation · Mar 2021
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
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
K191077 · Medtronic, Inc. · Aug 2019
Revolution Centrifugal Blood Pump
K190650 · Sorin Group Italia S.R.L. · Aug 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · Cardiacassist, Inc. · Jul 2019