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FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

K-Number: K203687 · 2021-05-28

ApplicantEdwards Lifesciences, LLC
Decision Date2021-05-28
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-05-28 under approval number K203687. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is a medical device that received FDA 510(k) clearance on 2021-05-28. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K203687.

When was HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index approved by the FDA?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index received FDA 510(k) clearance on 2021-05-28, under approval number K203687.

What company makes HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index is DQK.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT07604662 Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial NOT_YET_RECRUITING NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

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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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