# DEN190029: Acumen Assisted Fluid Management (AFM) Software Feature

- Pathway: De Novo (Direct)
- Applicant: Edwards Lifesciences
- Decided: Nov 13, 2020 after 529 days
- Product code: QMS (Adjunctive Open Loop Fluid Therapy Recommender)
- Device class: 2
- Regulation: 21 CFR 870.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), 14 descendants of its own
- K223865: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (2023), 7 descendants of its own
- K223651: Cerebral Adaptive Index (CAI) Algorithm (2023), 6 descendants of its own
- K223127: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (2022), 6 descendants of its own
- K230612: Edwards Algorithm for Measurement of Blood Hemoglobin (2023), 5 descendants of its own

## Indications for use
The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.

Source page: https://510kreport.com/device/DEN190029
Methodology: https://510kreport.com/methodology