# K230364: VitalFlow™ Console

- Pathway: 510(k) (Traditional)
- Applicant: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
- Decided: Aug 25, 2023 after 196 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: 1 generation back to K202751 (2021). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202751: TandemHeart Pump and Escort Controller, Cardiacassist, Inc. (2021) Summary page 4.

## Most influential descendants
- K250199: VitalFlow Console (2025), 0 descendants of its own

## 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/K230364
Methodology: https://510kreport.com/methodology