Cleared Traditional

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

K203224 · Edwards Lifesciences, LLC · Cardiovascular

Jul 2021

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K203224 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform, 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 July 30, 2021, 270 days after receiving the submission on November 2, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number	K203224 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2020
Decision Date	July 30, 2021
Days to Decision	270 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.