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FDA 510(k)

Acumen Assisted Fluid Management (AFM) Software Feature

K-Number: K233984 · 2024-08-02

ApplicantEdwards Lifesciences, LLC
Decision Date2024-08-02
Product CodeQMS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen Assisted Fluid Management (AFM) Software Feature is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-08-02 under approval number K233984. The device is classified under product code QMS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumen Assisted Fluid Management (AFM) Software Feature?

Acumen Assisted Fluid Management (AFM) Software Feature is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K233984.

When was Acumen Assisted Fluid Management (AFM) Software Feature approved by the FDA?

Acumen Assisted Fluid Management (AFM) Software Feature received FDA 510(k) clearance on 2024-08-02, under approval number K233984.

What company makes Acumen Assisted Fluid Management (AFM) Software Feature?

Acumen Assisted Fluid Management (AFM) Software Feature is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Acumen Assisted Fluid Management (AFM) Software Feature?

The FDA product code for Acumen Assisted Fluid Management (AFM) Software Feature is QMS.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT03768648 Cognition and MRI Markers in MS Patients With Aubagio® Treatment COMPLETED NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025) PMID: 40409423 Navigating regulatory challenges across the life cycle of a SaMD. Journal of biomedical informatics (2025)

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

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Related Devices (Code: QMS)

DEN190029Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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