Cleared Traditional

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 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183646 · Edwards Lifeciences, LLC · Cardiovascular device
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May 2019
Decision
146d
Days
Class 2
Risk

K183646 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypote.... Classified as Adjunctive Predictive Cardiovascular Indicator (product code QAQ), Class II - Special Controls.

Submitted by Edwards Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 21, 2019 after a review of 146 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifeciences, LLC devices

Submission Details

510(k) Number K183646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K183646.
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K203224 · Edwards Lifesciences, LLC · Jul 2021