Acumen Assisted Fluid Management (AFM) Software Feature
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233984 FDA 510(k)
- FDA Product Code
- QMS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5600 FDA 510(k)
- Regulation Number
- 870.5600 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acumen Assisted Fluid Management (AFM) Software Feature is an adjunctive open loop fluid therapy recommender device. It is classified as a Class II medical device under regulation number 870.5600 and is intended for use in cardiovascular applications.
The device is supplied as a software feature and is authorised under FDA 510(k) clearance K233984. It is manufactured by Edwards Lifesciences LLC in Irvine, California, and is intended for use with compatible monitoring systems such as the HemoSphere advanced monitor.
Frequently asked questions
What is the Acumen Assisted Fluid Management (AFM) Software Feature used for?
The Acumen Assisted Fluid Management (AFM) Software Feature is an adjunctive open loop fluid therapy recommender device intended for use in cardiovascular applications, providing therapy recommendations to support fluid management decisions when used with compatible monitoring systems.
How is the Acumen AFM Software Feature supplied and what equipment is it compatible with?
The device is supplied as a software feature and is intended for use with compatible monitoring systems such as the HemoSphere advanced monitor, meaning it is not a standalone hardware device but a functional addition to existing Edwards Lifesciences monitoring platforms.
Is the Acumen AFM Software Feature a single-use or reusable product?
As a software feature, the Acumen AFM is not a physical product subject to single-use or reuse limitations; its functionality is enabled via software licensing or activation on compatible hardware, and reuse depends on the underlying monitor's configuration and software terms.
What regulatory pathway was used for the Acumen AFM Software Feature?
The Acumen Assisted Fluid Management (AFM) Software Feature received FDA 510(k) clearance under submission K233984, indicating it was found substantially equivalent to a legally marketed predicate device for its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acumen Assisted Fluid Management software | Edwards Lifesciences, Acumen intelligent decision support suite | Edwards Lifesciences, PDF Acumen Assisted Fluid Management (AFM) software on HemoSphere advanced ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233984 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K233984 24 fields · synced Sep 21, 2026