# K254255: S-Patch CardioAI

- Pathway: 510(k) (Traditional)
- Applicant: Wellysis Corp.
- Decided: Sep 25, 2026 after 270 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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
S-Patch CardioAI is a software application intended for the assessment of cardiac arrhythmias using ambulatory ECG data in adults. It is intended for use by a healthcare solution integrator to build web, mobile, or other types of applications that allow qualified healthcare professionals to review and confirm the analytic results. The product supports downloading and analyzing data recorded in compatible formats from FDA-cleared S-Patch Ex and S-Patch ExL devices when assessment of the rhythm is necessary. S-Patch CardioAI can be electronically interfaced to perform analysis on data transferred from other computer-based ECG systems, such as an ECG management system. S-Patch CardioAI is not intended for use in life-supporting or life-sustaining systems or ECG Alarm devices. The interpretation results generated by S-Patch CardioAI are not intended to be the sole means of diagnosis. Interpretation of the device output must be made by the clinician; the results are offered to physicians and clinicians on an advisory basis only, to be used in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. CAUTION - Federal (U.S.) law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K254255
Methodology: https://510kreport.com/methodology