What product code is DEN160044?

QAQ: Adjunctive Predictive Cardiovascular Indicator, regulated under 21 CFR 870.2210, class 2.

FDA De Novo · Edwards Lifesciences

DEN160044: Acumen Hypotension Prediction Index (HPI) Feature Software (Edwards Lifesciences, LLC)

Q: Is Acumen Hypotension Prediction Index (HPI) Feature Software FDA authorized?

FDA's records list DEN160044 for Acumen Hypotension Prediction Index (HPI) Feature Software from Edwards Lifesciences, LLC: De Novo, decision date Mar 16, 2018. The De Novo pathway means the device was granted marketing authorization, not approved.

Edwards Lifesciences, LLC received FDA De Novo DEN160044 for Acumen Hypotension Prediction Index (HPI) Feature Software, with a decision date of Mar 16, 2018.

Prescription or OTC: Unknown (no FDA document we parsed states it).

FDA record for DEN160044 FDA decision summary (PDF)

FDA facts

Official fields for DEN160044
FDA number	DEN160044
Pathway	De Novo
Applicant	Edwards Lifesciences, LLC
Device name	Acumen Hypotension Prediction Index (HPI) Feature Software
Product code	QAQ: Adjunctive Predictive Cardiovascular Indicator
Regulation (21 CFR)	870.2210
Device class	Class 2
Date received	Sep 26, 2016
Decision date	Mar 16, 2018
Decision	Unknown (DENG)

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 3 records in this database cite DEN160044 as a predicate (listed below).

Later records that cite DEN160044

K230057 Acumen Hypotension Prediction Index (HPI) Algorithm (Edwards Lifesciences, Jun 8, 2023, QAQ)
K203224 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (Edwards Lifesciences, Jul 30, 2021, QAQ)
K183646 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 Lifesciences, May 21, 2019, QAQ)

ChatPPG interpretation

A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.2210). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.

Product code QAQ is "Adjunctive Predictive Cardiovascular Indicator", class 2, 21 CFR 870.2210. FDA's 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."

Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.