# K243252: ZBPro Diagnostic

- Pathway: 510(k) (Traditional)
- Applicant: Zbeats, Inc.
- Decided: Jul 10, 2025 after 268 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: 6 generations back to K003621 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K261580: ZBPro Diagnostic (Version 2.0) (2026), 0 descendants of its own

## Indications for use
ZBPro Diagnostic is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in Holter ECG data in the adult, non-paced population. The product supports downloading and analyzing Lead II, CM5 (Ch 1), or Modified-MLII (Ch 2+) on retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings collected using standard Ag/AgCl wet electrodes in adult, non-paced patients. ZBPro is not intended for use with multi-lead analysis, wearable patches, or pediatric/paced recordings. ZBPro Diagnostic can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. ZBPro Diagnostic provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis. ZBPro Diagnostic 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. ZBPro Diagnostic 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/K243252
Methodology: https://510kreport.com/methodology