Cleared Traditional

Hypertension Prediction Index (HePI) Algorithm

K242518 · Edwards Lifesciences, LLC · Cardiovascular

May 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K242518 is an FDA 510(k) clearance for the Hypertension Prediction Index (HePI) Algorithm, a Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QAQ), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 15, 2025, 265 days after receiving the submission on August 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number	K242518 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2024
Decision Date	May 15, 2025
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QAQ — Adjunctive Predictive Cardiovascular Indicator
Device Class	Class II — 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.