# K261335: VitalFlow Set with Balance™ Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jul 31, 2026 after 99 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: 7 generations back to K932252 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240880: VitalFlow Set with Balance Biosurface, Medtronic, Inc. (2024) Summary page 5.

## 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 of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.

Source page: https://510kreport.com/device/K261335
Methodology: https://510kreport.com/methodology