# K212112: Cardiologs Holter Platform

- Pathway: 510(k) (Traditional)
- Applicant: Cardiologs Technologies
- Decided: Nov 18, 2021 after 135 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: 5 generations back to K003621 (2000). 5 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170568: CardioLogs ECG Analysis Platform, Cardiologs Technologies (2017) Summary page 5.

## Most influential descendants
- K243252: ZBPro Diagnostic (2025), 1 descendant of its own
- K223013: AccurECG Analysis System (2023), 1 descendant of its own
- K261580: ZBPro Diagnostic (Version 2.0) (2026), 0 descendants of its own
- K252978: ScioCardio ECG Analysis Platform (2026), 0 descendants of its own
- K252361: AccurECG Analysis System (v2.0) (2025), 0 descendants of its own

## Indications for use
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. Cardiologs Platform interpretation 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/K212112
Methodology: https://510kreport.com/methodology