# K233755: HeartKey® Rhythm

- Pathway: 510(k) (Traditional)
- Applicant: B-Secur Limited
- Decided: Aug 16, 2024 after 268 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: 14 generations back to K882803 (1988). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210822: DeepRhythmAI, Medicalgorithmics S.A. (2022) Summary page 5.

## Indications for use
HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults. HeartKey Rhythm analyses a single ECG lead recorded from compatible devices used for arrhythmia diagnostics such as Holters, Extended Holters, ECG Patches, Event Recorders, or other similar devices when assessment of the rhythm is necessary. The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities: • ECG signal conditioning, • ECG signal quality assessment, • QRS beat detection, • Ventricular ectopic beat detection, • ECG rhythm analysis HeartKey Rhythm is not intended for use in life supporting, or sustaining systems, or real-time ECG monitors, or cardiac alarm devices, or OTC-use only devices. HeartKey Rhythm analysis 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/K233755
Methodology: https://510kreport.com/methodology