# K231035: FusedCO Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 12, 2023 after 92 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K941811 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
1 of 179 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable, Edwards Lifesciences, LLC (2018) Summary page 4.

## Indications for use
The FusedCO Algorithm when used with Edwards' Swan-Ganz advanced technology pulmonary artery catheter and Acumen IQ sensor is indicated for use in adult critical care patients requiring monitoring of cardiac output and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

Source page: https://510kreport.com/device/K231035
Methodology: https://510kreport.com/methodology