510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160044Unknown

Acumen Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences LLC, Irvine CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160044 is the FDA 510(k) clearance record for Acumen Hypotension Prediction Index (HPI) Feature Software, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code QAQ (Adjunctive Predictive Cardiovascular Indicator). FDA's definition for product code QAQ reads: "The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use...". FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming DEN160044.

Clearance record

Decision date
Received
(536 days to decision)
Product code
QAQ Adjunctive Predictive Cardiovascular Indicator
Regulation
21 CFR 870.2210
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
Third party review
No

Clearances, product code QAQ

Trailing 12 months

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

FDA records show no clearances under product code QAQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAQ, 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