| K-number | K253034 |
| Device name | HemoSphere Stream Module |
| Applicant | Edwards Lifesciences |
| Product code | DQK |
| Device class | Class II |
| Decision date | Oct 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The HemoSphere Stream Module is a software-configured version of the HemoSphere ClearSight Module designed to provide continuous, non-invasive arterial blood pressure waveform output to compatible patient monitors in adult patients. It is used with a Smart Pressure Controller (PC1Q) and VitaWave Plus Finger Cuff in clinical settings requiring continuous assessment of blood pressure waveform morphology without invasive catheterization.
The HemoSphere Stream Module acquires and transmits only the continuous blood pressure waveform to the connected monitor, unlike the predicate ClearSight Module which also calculates and displays blood pressure parameters and derived hemodynamic parameters. The waveform acquisition and transmission methods are identical to the predicate device; the modification removes parameter calculation and display functionality for cost-effectiveness.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov