# K261580: ZBPro Diagnostic (Version 2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Zbeats, Inc.
- Decided: Sep 11, 2026 after 121 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003621 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243252: ZBPro Diagnostic, Zbeats, Inc. (2025) Summary page 6.

## Indications for use
ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population. The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead wearable ECG patch configurations that use wet gel electrodes. The device analyzes Lead II, CMS (Ch 1), Modified-MUI (Ch 2+), or MLII (single lead) but does not perform multi-lead analysis. ZBPro is not intended for use with paced signals or recordings taken from pediatric patients. ZBPro Diagnostic v2.0 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 v2.0 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 v2.0 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/K261580
Methodology: https://510kreport.com/methodology