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.

2
Total
1
Cleared
379d
Avg days
2020
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 228d recently vs 529d historically

FDA 510(k) Cleared Adjunctive Open Loop Fluid Therapy Recommender Devices (Product Code QMS)

2 devices
1–2 of 2
Cleared Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
K233984
Edwards Lifesciences, LLC
Cardiovascular · 228d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QMS have taken an average of 228 days to reach a decision - down from 529 days historically, suggesting improved FDA processing for this classification.

QMS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →