Cleared Traditional

DeepRhythmAI (K210822) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210822 · Medicalgorithmics S.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
495d
Days
Class 2
Risk

K210822 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 July 27, 2022 after a review of 495 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medicalgorithmics S.A. devices

Submission Details

510(k) Number K210822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2021
Decision Date July 27, 2022
Days to Decision 495 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
370d slower than avg
Panel avg: 125d · This submission: 495d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Medicalgorithmics US Holding Corporation
Agnieszka Romowicz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K210822.
AcQMap High Resolution Imaging and Mapping System
K222209 · Acutus Medical, Inc. · Oct 2022
EnSite X EP System
K221213 · Abbott · Aug 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · Biosense Webster, Inc. · Aug 2022
ZEUS System (Zio Watch)
K213409 · iRhythm Technologies, Inc. · Jul 2022
AcQMap High Resolution Imaging and Mapping System
K220784 · Acutus Medical, Inc. · Jul 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
K213682 · Edwards Lifesciences, LLC · Jun 2022