DeviceClearance

Product code QMS— Cardiovascular

Acumen Assisted Fluid Management (AFM) Software Feature

Classification name
Adjunctive Open Loop Fluid Therapy Recommender
Device class
Class 2
Regulation
21 CFR 870.5600
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QMS under 21 CFR 870.5600, via openFDA

Market context for product code QMS

FDA has cleared 2 devices under product code QMS between 2020 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QMS

Recent clearances under product code QMS

Data sourced from openFDA. This site is unofficial and independent of the FDA.