Cleared Traditional

K230364 - VitalFlow™ Console (FDA 510(k) Clearance)

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

K230364 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · Cardiovascular device
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Aug 2023
Decision
196d
Days
Class 2
Risk

K230364 is an FDA 510(k) clearance for the VitalFlow™ Console. Classified as Blood Pump For Ecmo, Long-term (> 6 Hours) Use (product code QNR), Class II - Special Controls.

Submitted by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (Dexter, US). The FDA issued a Cleared decision on August 25, 2023 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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 Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) devices

Submission Details

510(k) Number K230364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2023
Decision Date August 25, 2023
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNR Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
Definition A Blood Pump For Long-term Circulatory Support Is A Device Intended For Use As Part Of An Extracorporeal Circuit Intended To Provide Assisted Extracorporeal Circulation And Physiologic Gas Exchange Of The Patient's Blood In Patients With Acute Respiratory Failure Or Acute Cardiopulmonary Failure Where Other Available Treatment Options Have Failed And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
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 - QNR Blood Pump For Ecmo, Long-term (> 6 Hours) Use

All 7
Devices cleared under the same product code (QNR) and FDA review panel - the closest regulatory comparables to K230364.
VitalFlow Console
K250199 · Medtronic, Inc. · May 2025
CentriMag™ Acute Circulatory Support System
K234118 · Abbott Medical · Jan 2024
LifeSPARC System
K233736 · Cardiacassist, Inc. · Jan 2024
VitalFlowTM Centrifugal Pump
K223898 · Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) · Aug 2023
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
K222038 · Abbott (Formerly Thoratec Corporation) · Dec 2022
LifeSPARC System
K211830 · Cardiacassist, Inc. · Nov 2022