QMS — Adjunctive Open Loop Fluid Therapy Recommender Class II

FDA Device Classification

Classification Details

Product Code
QMS
Device Class
Class II
Regulation Number
870.5600
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233984edwards lifesciencesAcumen Assisted Fluid Management (AFM) Software FeatureAugust 2, 2024
DEN190029edwards lifesciencesAcumen Assisted Fluid Management (AFM) Software FeatureNovember 13, 2020