Cleared Traditional

Acumen Hypotension Prediction Index ? EV1000 Clinical Platform, Acumen Hypotension Prediction Index ? HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index ? HemoSphere Advanced Monitoring Platform - Pressure

K183646 · Edwards Lifeciences, LLC · Cardiovascular

May 2019

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K183646 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index ? EV1000 Clinical Platform, Acumen Hypotension Prediction Index ? HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index ? HemoSphere Advanced Monitoring Platform - Pressure, a Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QAQ), submitted by Edwards Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 21, 2019, 146 days after receiving the submission on December 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number	K183646 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2018
Decision Date	May 21, 2019
Days to Decision	146 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.