# K223898: VitalFlowTM Centrifugal Pump

- Pathway: 510(k) (Traditional)
- Applicant: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
- Decided: Aug 25, 2023 after 240 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: none
- 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in 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™ Console and Drive Motor, or the Emergency Handcrank.

Source page: https://510kreport.com/device/K223898
Methodology: https://510kreport.com/methodology