Devices · Edwards Lifesciences, LLC

Acumen Assisted Fluid Management (AFM) Software Feature

Edwards Lifesciences, LLC is listed for Acumen Assisted Fluid Management (AFM) Software Feature (K233984). The FDA list gives August 2, 2024 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QMS as “Adjunctive Open Loop Fluid Therapy Recommender”: The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233984

Official FDA database record

Date of final decision

August 2, 2024

Company on the FDA list

Edwards Lifesciences, LLC

Lead panel

Cardiovascular

Primary product code

QMS

openFDA device name for the code

Adjunctive Open Loop Fluid Therapy Recommender

Device class

2

Regulation number

870.5600

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary