# K252978: ScioCardio ECG Analysis Platform

- Pathway: 510(k) (Traditional)
- Applicant: Synergen Technology Labs, LLC
- Decided: Jul 9, 2026 after 295 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: 6 generations back to K003621 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212112: Cardiologs Holter Platform, Cardiologs Technologies (2021) Summary page 6.

## Indications for use
The ScioCardio ECG Analysis Platform is intended for use by healthcare professionals or trained personnel in healthcare facilities for the assessment of cardiac rhythms and arrhythmias using ECG data in adults aged 22 years and older. The ScioCardio ECG Analysis Platform supports analyzing ECG data recorded from the ScioCardio ECG transmitter (K171019). The ScioCardio ECG Analysis platform provides ECG signal processing and analysis including QRS complex detection, beat classification, and rhythm analysis. The reports include beat-by-beat analysis, heart rate measurement, and rhythm analysis. The ScioCardio ECG Analysis Platform is not intended for use in life-supporting or sustaining systems, or for real-time ECG monitoring or alarm functions. Interpretation results provided by the ScioCardio are not intended to be the sole means of diagnosis and are offered as an advisory aid to be used alongside clinician review, ECG patterns, patient history, clinical indications, and other diagnostic data.

Source page: https://510kreport.com/device/K252978
Methodology: https://510kreport.com/methodology