Edwards Lifesciences · Class II · Cleared Jul 23, 2025
| K-number | K243781 |
| Device name | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) |
| Applicant | Edwards Lifesciences |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jul 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The HemoSphere Advanced Monitoring Platform is a modular hemodynamic monitoring system for critical care patients in hospital settings. It combines multiple measurement modules (Swan-Ganz, oximetry, pressure, ClearSight, ForeSight, technology) to provide continuous and intermittent cardiac output, blood pressure, oxygen saturation, and derived hemodynamic parameters for adult and pediatric patients in operating rooms, ICUs, and emergency departments.
The subject device uses the same base platform hardware as the predicate (K223865, cleared June 2023) but includes new hardware configurations: a Smart Pressure Controller (PC1Q) with hydrostatic height correction between finger and heart, and updated Acumen IQ Plus and VitaWave Plus finger cuffs (AIQCA2, VWCA2). Software updates support new GUI features including Fluid Meter Only Mode, pulse rate option for parameter calculation, HPI Adjustable MAP integration, and miscellaneous usability enhancements. All accessories and components remain substantially the same.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366-1, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49, and IEC 80601-2-49. Software verification followed FDA guidance for premarket submissions for software in medical devices.
The subject device maintains identical intended use and indications to the predicate (K223865) and secondary predicate (K242451): hemodynamic monitoring in critical care. Hardware and software modifications (new pressure controller configuration, finger cuff variants, GUI updates) do not alter the fundamental function or technological basis—all measure and display the same hemodynamic parameters through the same measurement modalities. Completed verification testing including usability, bench simulation, system integration, mechanical, electrical, EMC, and software verification confirmed that design differences do not adversely affect safety or effectiveness, demonstrating substantial equivalence.
View the full FDA submission: accessdata.fda.gov