Cleared Traditional

K251762 - Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (FDA 510(k) Clearance)

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

K251762 · Spectrum Medical S.R.L. · Cardiovascular device
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Aug 2025
Decision
56d
Days
Class 2
Risk

K251762 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20.... 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 August 4, 2025 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spectrum Medical S.R.L. devices

Submission Details

510(k) Number K251762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2025
Decision Date August 04, 2025
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K251762.
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
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