Cleared Traditional

DeepRhythmAI

K250932 · Medicalgorithmics S.A. · Cardiovascular
May 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K250932 is an FDA 510(k) clearance for the DeepRhythmAI, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on May 27, 2025, 60 days after receiving the submission on March 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K250932 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date May 27, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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