Devices · Edwards Lifeciences, LLC

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

Edwards Lifeciences, LLC is listed for 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). The FDA list gives May 21, 2019 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QAQ as “Adjunctive Predictive Cardiovascular Indicator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183646

Official FDA database record

Date of final decision

May 21, 2019

Company on the FDA list

Edwards Lifeciences, LLC

Lead panel

Cardiovascular

Primary product code

QAQ

openFDA device name for the code

Adjunctive Predictive Cardiovascular Indicator

Device class

2

Regulation number

870.2210

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary