# K233984: Acumen Assisted Fluid Management (AFM) Software Feature

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 2, 2024 after 228 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
Longest line of descent: 30 generations back to K941811 (1994). 248 ancestors in all.
No later device cites it as a predicate yet.
1 of 249 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Edwards Lifesciences, LLC (2023) Summary page 5.

## 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/K233984
Methodology: https://510kreport.com/methodology