Cleared Traditional

K220842 - Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

K220842 is an FDA 510(k) clearance for Quantum Perfusion Centrifugal Blood Pum..., 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 422-day FDA review.

K220842 · Qura S.R.L · Cardiovascular device
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May 2023
Decision
422d
Days
Class 2
Risk

K220842 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantu.... 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 May 19, 2023 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Qura S.R.L devices

FDA 510(k) Submission Details - K220842

510(k) Number K220842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2022
Decision Date May 19, 2023
Days to Decision 422 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 125d · This submission: 422d
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 74
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K220842.
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
K250326 · Spectrum Medical S.R.L. · Jun 2025
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091 · Qura S.R.L · Oct 2023
LifeSPARC System
K232132 · Cardiacassist, Inc. · Aug 2023
Capiox iCP Centrifugal Pump
K200091 · Terumo Cardiovascular Systems Corporation · Nov 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · Qura S.R.L · Nov 2021
FloPump 57mL Centrifugal Pump
K193663 · International Biophysics Corporation · Mar 2021