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FDA 510(k)

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

K-Number: K183646 · 2019-05-21

ApplicantEdwards Lifeciences, LLC
Decision Date2019-05-21
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is a medical device manufactured by Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2019-05-21 under approval number K183646. 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 Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is a medical device that received FDA 510(k) clearance on 2019-05-21. It is manufactured by Edwards Lifeciences, LLC. The 510(k) number is K183646.

When was Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure approved by the FDA?

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure received FDA 510(k) clearance on 2019-05-21, under approval number K183646.

What company makes Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is manufactured by Edwards Lifeciences, LLC.

What is the FDA product code for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure?

The FDA product code for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is QAQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42144441 A workflow utilizing general-purpose large language models for efficient structuring and data mining of bone scintigraphy narratives. Scientific reports (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41832928 Artificial intelligence as medical device in radiology in 2025: the regulatory scenario in the EU, USA, and China. European radiology (2026)

Other Devices by Edwards Lifeciences, LLC

K183413TruWave Disposable Pressure Transducer K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

Related Devices (Code: QAQ)

DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, 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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