# K210822: DeepRhythmAI

- Pathway: 510(k) (Traditional)
- Applicant: Medicalgorithmics S.A.
- Decided: Jul 27, 2022 after 495 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K882803 (1988). 56 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182344: RhythmAnalytics, Biofourmis Singapore Pte., Ltd. (2019) Summary page 4.
- K181502: Zio AT ECG Monitoring System, ZEUS System, iRhythm Technologies, Inc. (2018) Summary page 4.

## Most influential descendants
- K241197: DeepRhythmAI (2024), 3 descendants of its own
- K250932: DeepRhythmAI (2025), 1 descendant of its own
- K254255: S-Patch CardioAI (2026), 0 descendants of its own
- K253141: DeepRhythmAI (2025), 0 descendants of its own
- K242129: VitalRhythm (2025), 0 descendants of its own

## Indications for use
DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

Source page: https://510kreport.com/device/K210822
Methodology: https://510kreport.com/methodology