# K240880: VitalFlow Set with Balance Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Sep 12, 2024 after 164 days
- Product code: QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure)
- 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: 6 generations back to K932252 (1993). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191407: Novalung System, Fresenius Medical Care Renal Therapies Group, LLC (2020) Summary page 5.

## Most influential descendants
- K261335: VitalFlow Set with Balance™ Biosurface (2026), 0 descendants of its own

## Indications for use
The VitalFlow Set with Balance Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation) of the patient's blood in adults 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.

Source page: https://510kreport.com/device/K240880
Methodology: https://510kreport.com/methodology