Cleared Traditional

K203224 - Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K203224 · Edwards Lifesciences, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
270d
Days
Class 2
Risk

K203224 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform. Classified as Adjunctive Predictive Cardiovascular Indicator (product code QAQ), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 30, 2021 after a review of 270 days - an extended review cycle.

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 Lifesciences, LLC devices

Submission Details

510(k) Number K203224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date July 30, 2021
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03805217 Completed Observational Industry-sponsored

Hypotension Prediction Index Study (HPI Study)

Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software

485
Patients (actual)
11
Sites
Condition studied Hypotension
Eligibility All sexes · 18 Years+
Principal investigator Tina Abdelnour, MS, BSN
Sponsor Edwards Lifesciences (industry)
Started 2019-05-16 → Primary completion 2020-03-17
Primary outcome
Reduction of Intraoperative Hypotension
Secondary outcome
Intraoperative Hypotension in Each Subject
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov