Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HemoSphere Advanced Monitor, HemoSphere ClearSight Module

K-Number: K221833 · 2022-11-07

ApplicantEdwards Lifesciences, LLC
Decision Date2022-11-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitor, HemoSphere ClearSight Module is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2022-11-07 under approval number K221833. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Advanced Monitor, HemoSphere ClearSight Module?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K221833.

When was HemoSphere Advanced Monitor, HemoSphere ClearSight Module approved by the FDA?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module received FDA 510(k) clearance on 2022-11-07, under approval number K221833.

What company makes HemoSphere Advanced Monitor, HemoSphere ClearSight Module?

HemoSphere Advanced Monitor, HemoSphere ClearSight Module is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module?

The FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module is DXN.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07592611 Deep Brain Stimulation for Treatment-Resistant Schizophrenia NOT_YET_RECRUITING NCT02361554 Deep Brain Stimulation in Treatment Resistant Schizophrenia TERMINATED NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants 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)

Other Devices by Edwards Lifesciences, LLC

K161962VAMP Venous/Arterial Blood Management Protection System K160645PreSep Oligon Oximetry Catheter K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160084Swan Ganz Catheters K152980Flo Trac sensor, Volume View sensor K172660Duravess bovine pericardial vascular patch

View all 64 devices →

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

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.

↑