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 Patients 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 and Edwards Lifesciences, LLC.
2
Total
1
Cleared
379d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Adjunctive Open Loop Fluid Therapy Recommender Devices (Product Code QMS)
2 devices
Cleared
Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
Cardiovascular
228d
Not Cleared
Nov 13, 2020
Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences
Cardiovascular
529d
About Product Code QMS - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QMS since 2020, with 1 receiving FDA clearance (average review time: 379 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.