Cleared Traditional

K233984 - Acumen Assisted Fluid Management (AFM) Software Feature (FDA 510(k) Clearance)

K233984 · Edwards Lifesciences, LLC · Cardiovascular device
Aug 2024
Decision
228d
Days
Class 2
Risk

K233984 is an FDA 510(k) clearance for the Acumen Assisted Fluid Management (AFM) Software Feature. This device is classified as a Adjunctive Open Loop Fluid Therapy Recommender (Class II - Special Controls, product code QMS).

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 2, 2024, 228 days after receiving the submission on December 18, 2023.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5600. The Adjunctive Open Loop Fluid Therapy Recommender Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict A Patient’s 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..

Submission Details

510(k) Number K233984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date August 02, 2024
Days to Decision 228 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QMS — Adjunctive Open Loop Fluid Therapy Recommender
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.5600
Definition The Adjunctive Open Loop Fluid Therapy Recommender Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict A Patient’s 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.