Not Cleared Direct

DEN160044 - Acumen Hypotension Prediction Index (HPI) Feature Software (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160044 · Edwards Lifesciences, LLC · Cardiovascular device
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Mar 2018
Decision
536d
Days
Class 2
Risk

DEN160044 is an FDA 510(k) submission (not cleared) for the Acumen Hypotension Prediction Index (HPI) Feature Software. Classified as Adjunctive Predictive Cardiovascular Indicator (product code QAQ), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Not Cleared (DENG) decision on March 16, 2018 after a review of 536 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 536 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN160044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 26, 2016
Decision Date March 16, 2018
Days to Decision 536 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
411d slower than avg
Panel avg: 125d · This submission: 536d
Pathway characteristics

Device Classification

Product Code QAQ Adjunctive Predictive Cardiovascular Indicator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QAQ Adjunctive Predictive Cardiovascular Indicator

Devices cleared under the same product code (QAQ) and FDA review panel - the closest regulatory comparables to DEN160044.
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