Cleared Traditional

Edema Guard Monitor (EGM) CardioSet-001

K250922 · Cardioset Medical , Ltd. · Cardiovascular

Sep 2025

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K250922 is an FDA 510(k) clearance for the Edema Guard Monitor (EGM) CardioSet-001, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Cardioset Medical , Ltd. (Matan, IL). The FDA issued a Cleared decision on September 9, 2025, 166 days after receiving the submission on March 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number	K250922 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2025
Decision Date	September 09, 2025
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF