Cleared Traditional

DeepRhythmAI

K253141 · Medicalgorithmics S.A. · Cardiovascular
Dec 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K253141 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 December 11, 2025, 77 days after receiving the submission on September 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K253141 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2025
Decision Date December 11, 2025
Days to Decision 77 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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