Cleared Traditional

eMurmur Heart AI

K252284 · Csd Labs · Cardiovascular

Dec 2025

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K252284 is an FDA 510(k) clearance for the eMurmur Heart AI, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Csd Labs (Graz, AT). The FDA issued a Cleared decision on December 19, 2025, 150 days after receiving the submission on July 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K252284 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2025
Decision Date	December 19, 2025
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF