510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233984Substantially Equivalent

Acumen Assisted Fluid Management (AFM) Software Feature

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233984 is the FDA 510(k) clearance record for Acumen Assisted Fluid Management (AFM) Software Feature, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code QMS (Adjunctive Open Loop Fluid Therapy Recommender). FDA's definition for product code QMS reads: "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...". FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K233984.

Clearance record

Decision date
Received
(228 days to decision)
Product code
QMS Adjunctive Open Loop Fluid Therapy Recommender
Regulation
21 CFR 870.5600
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QMS

Trailing 12 months

FDA records hold no clearances under product code QMS in the trailing twelve months.

FDA records show no clearances under product code QMS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260