Cleared Traditional

K241197 - DeepRhythmAI

K241197 is an FDA 510(k) clearance for DeepRhythmAI, manufactured by Medicalgorithmics S.A.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K241197 · Medicalgorithmics S.A. · Cardiovascular device
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Dec 2024
Decision
218d
Days
Class 2
Risk

K241197 is an FDA 510(k) clearance for the DeepRhythmAI. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Medicalgorithmics S.A. (Warsaw, PL). The FDA issued a Cleared decision on December 4, 2024 after a review of 218 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medicalgorithmics S.A. devices

FDA 510(k) Submission Details - K241197

510(k) Number K241197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2024
Decision Date December 04, 2024
Days to Decision 218 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 125d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 268
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K241197.
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K242133 · Centerline Biomedical, Inc. · Oct 2024
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K241227 · Boston Scientific Corporation · Aug 2024