# K223168: Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 19, 2023 after 190 days
- Product code: QWF (Tubing, Long Term Support Greater Than 6 Hours)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FDA Final Order 81 FR 7451, February 12, 2016: named in the summary without a submission number

## Indications for use
The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when 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/K223168
Methodology: https://510kreport.com/methodology