Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 2, 2024 after a review of 228 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5600 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QMS Adjunctive Open Loop Fluid Therapy Recommender
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.