Cleared Traditional

K250326 - Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250326 · Spectrum Medical S.R.L. · Cardiovascular device
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Jun 2025
Decision
139d
Days
Class 2
Risk

K250326 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22.... Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 24, 2025 after a review of 139 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 Spectrum Medical S.R.L. devices

Submission Details

510(k) Number K250326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2025
Decision Date June 24, 2025
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 83
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K250326.
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
K251762 · Spectrum Medical S.R.L. · Aug 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
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
K220842 · Qura S.R.L · May 2023
Capiox iCP Centrifugal Pump
K200091 · Terumo Cardiovascular Systems Corporation · Nov 2021