# K242129: VitalRhythm

- Pathway: 510(k) (Traditional)
- Applicant: Vitalconnect, Inc.
- Decided: Apr 17, 2025 after 269 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: 15 generations back to K882803 (1988). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241197: DeepRhythmAI, Medicalgorithmics S.A. (2024). Cleared while this submission was under review Summary page 6.

## Indications for use
VitalRhythm is a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias. VitalRhythm is compatible with the “Vista Solution” platform, which includes the VitalPatch biosensor and VistaCenter web application. VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making. VitalRhythm provides analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch in patients who are 18 years of age or older. Results of the VitalRhythm are displayed within the VistaCenter web application to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians. VitalRhythm is not intended for use in life-supporting or sustaining systems or for critical care monitoring. The arrhythmia analysis results are not intended to be the sole means of diagnosis and are offered 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/K242129
Methodology: https://510kreport.com/methodology