Cleared Traditional

Acumen Hypotension Prediction Index (HPI) Algorithm

K230057 · Edwards Lifesciences, LLC · Cardiovascular

Jun 2023

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K230057 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index (HPI) Algorithm, a Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QAQ), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 8, 2023, 150 days after receiving the submission on January 9, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number	K230057 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 2023
Decision Date	June 08, 2023
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QAQ — Adjunctive Predictive Cardiovascular Indicator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2210
Definition	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 With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.