# K182344: RhythmAnalytics

- Pathway: 510(k) (Traditional)
- Applicant: Biofourmis Singapore Pte., Ltd.
- Decided: Mar 7, 2019 after 191 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: 5 generations back to K003621 (2000). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170568: CardioLogs ECG Analysis Platform, Cardiologs Technologies (2017) Summary page 4.

## Most influential descendants
- K210822: DeepRhythmAI (2022), 6 descendants of its own
- 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

## Indications for use
RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when assessment of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product 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. RhythmAnalytics 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/K182344
Methodology: https://510kreport.com/methodology