# K232974: EKGenius Smart System

- Pathway: 510(k) (Traditional)
- Applicant: Ekgenius, LLC
- Decided: Nov 17, 2023 after 57 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EKGenius Smart System is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to EKGenius Smart System software, which is installed on an iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs. The EKGenius Smart System is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor. The EKGenius Smart System is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance. The EKGenius Smart System provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

Source page: https://510kreport.com/device/K232974
Methodology: https://510kreport.com/methodology