1 device · 1 company · 2024
Product code QMS: Adjunctive Open Loop Fluid Therapy Recommender
1 device under product code QMS, 2024, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Adjunctive Open Loop Fluid Therapy Recommender. 21 CFR 870.5600, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Acumen Assisted Fluid ManagementK233984 · 510(k) | Edwards Lifesciences, LLC | Cardiovascular | database entry |
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