Cleared Traditional

K201320 - Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (FDA 510(k) Clearance)

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

K201320 · Qura S.R.L · Cardiovascular device

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Nov 2021

Decision

534d

Days

Class 2

Risk

K201320 is an FDA 510(k) clearance for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor. 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 November 3, 2021 after a review of 534 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

Submission Details

510(k) Number	K201320 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 2020
Decision Date	November 03, 2021
Days to Decision	534 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

409d slower than avg

Panel avg: 125d · This submission: 534d

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.