# K250199: VitalFlow Console

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 20, 2025 after 117 days
- Product code: QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K202751 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230364: VitalFlow™ Console, Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (2023) Summary page 5.

## Recalls of this device
- Oct 3, 2025 · Class II · Z-0509-2026: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresp

## Indications for use
The VitalFlow Console controls the speed of the VitalFlow Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult 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. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank

Source page: https://510kreport.com/device/K250199
Methodology: https://510kreport.com/methodology