Cleared Traditional

K243781 - HemoSphere Advanced Monitor (HEM1) (FDA 510(k) Clearance)

Also includes:

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)

K243781 · Edwards Lifesciences · Cardiovascular device

Jul 2025

Decision

226d

Days

Class 2

Risk

K243781 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor (HEM1). This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on July 23, 2025, 226 days after receiving the submission on December 9, 2024.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number	K243781 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 09, 2024
Decision Date	July 23, 2025
Days to Decision	226 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF