ZBPro Diagnostic (Version 2.0)— 510(k) K261580

Name: FDA 510(k) clearance K261580
Creator: U.S. Food and Drug Administration
Published: 2026-09-11

Substantially Equivalent

Zbeats, Inc.

FDA 510(k) clearance K261580 for ZBPro Diagnostic (Version 2.0), Substantially Equivalent on 2026-09-11. Applicant: Zbeats, Inc.. Device class: 2.

Summary

ZBPro Diagnostic (Version 2.0) is ECG analysis software under MLO, ambulatory electrocardiographs with an analysis algorithm. Unlike a plain recorder, an MLO device runs its own automated rhythm analysis. The 2.0 suggests an update to an earlier version.

Class II, 21 CFR 870.2800. The Cardiovascular panel reviewed it as a Traditional 510(k).

Zbeats filed from Stony Brook, New York. Review took 121 days (May 13 to September 11, 2026). That's quick for arrhythmia detection software, which normally has to show algorithm performance against annotated reference databases.

Clearance details

Applicant: Zbeats, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2026-05-13
Decision date: 2026-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

Download summary PDF View on FDA.gov ↗

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