Cleared Traditional

VitalFlow Console

K250199 · Medtronic, Inc. · Cardiovascular

May 2025

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K250199 is an FDA 510(k) clearance for the VitalFlow Console, a Blood Pump For Ecmo, Long-term (> 6 Hours) Use (Class II — Special Controls, product code QNR), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 20, 2025, 117 days after receiving the submission on January 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K250199 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2025
Decision Date	May 20, 2025
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QNR — Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Device Class	Class II — 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.