Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Q: What is the product code of K203224?

The FDA product code is QAQ – Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.

FDA 510(k) K203224 · Edwards Lifesciences, LLC

Substantially Equivalent

510(k) numberK203224

Submission

Device name: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Applicant: Edwards Lifesciences, LLC
Irvine, CA, US
Received: November 2, 2020
Decision date: July 30, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QAQ – Adjunctive Predictive Cardiovascular Indicator
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2210
Specialty: Cardiovascular

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.

Other 510(k)s with product code QAQ

510(k)	Device	Applicant	Decision
K242518	Hypertension Prediction Index (HePI) AlgorithmQAQ · Traditional	Edwards Lifesciences, LLC	05/15/2025SE
K230057	Acumen Hypotension Prediction Index (HPI) AlgorithmQAQ · Traditional	Edwards Lifesciences, LLC	06/08/2023SE
K183646	Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension…QAQ · Traditional	Edwards Lifeciences, LLC	05/21/2019SE

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Questions and answers

When was Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform cleared by the FDA?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (K203224) received a 510(k) decision of Substantially Equivalent on July 30, 2021, 270 days after the submission was received.

What is the product code of K203224?

The FDA product code is QAQ – Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.