Cleared Traditional

K250326 - Quantum Perfusion Centrifugal Blood Pum...

K250326 is an FDA 510(k) clearance for Quantum Perfusion Centrifugal Blood Pum..., manufactured by Spectrum Medical S.R.L.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 139-day FDA review.

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

FDA 510(k) Submission Details - K250326

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.

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 44
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
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · Qura S.R.L · Nov 2021