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FDA 510(k)

Hypertension Prediction Index (HePI) Algorithm

K-Number: K242518 · 2025-05-15

ApplicantEdwards Lifesciences, LLC
Decision Date2025-05-15
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypertension Prediction Index (HePI) Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242518. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypertension Prediction Index (HePI) Algorithm?

Hypertension Prediction Index (HePI) Algorithm is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K242518.

When did Hypertension Prediction Index (HePI) Algorithm receive FDA 510(k) clearance?

Hypertension Prediction Index (HePI) Algorithm received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242518.

Who is the listed applicant for Hypertension Prediction Index (HePI) Algorithm?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypertension Prediction Index (HePI) Algorithm?

The FDA product code for Hypertension Prediction Index (HePI) Algorithm is QAQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05083403HPI (Hypotension Prediction Index) Care TrialTERMINATEDNCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITING

Other records listing Edwards Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

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Related Devices (Code: QAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLCK203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLCK183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureEdwards Lifeciences, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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