QMS · Class II · 21 CFR 870.5600

FDA Product Code QMS: 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.

Leading manufacturers include Edwards Lifesciences, LLC.

1
Total
1
Cleared
228d
Avg days
2024
Since

List of Adjunctive Open Loop Fluid Therapy Recommender devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
K233984
Edwards Lifesciences, LLC
Cardiovascular · 228d

How to use this database

This page lists all FDA 510(k) submissions for Adjunctive Open Loop Fluid Therapy Recommender devices (product code QMS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →